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Code · REGISTER · 2007-11-30 · Unknown

Unknown. Final rule; technical amendment

34,583 words·~157 min read·/register/2007/11/30/07-5887

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2007-11-30.xml --- 72 230 Friday, November 30, 2007 Contents Agency Agency for Healthcare Research and Quality NOTICES Agency information collection activities; proposals, submissions, and approvals, 67732-67733 07-5886 Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service See Natural Resources Conservation Service Animal Animal and Plant Health Inspection Service RULES Interstate transportation of animal and animal products (quarantine):
Brucellosis in cattle— State and area classifications, 67635-67636 E7-23254 Plant-related quarantine, foreign: Nursery stock; technical amendment, 67635 E7-23282 NOTICES Committees; establishment, renewal, termination, etc.: National Wildlife Services Advisory Committee, 67696 E7-23195 Blind Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Census Census Bureau NOTICES Surveys, determinations, etc.:
Manufacturing area; annual, 67699-67700 E7-23250 Service industries; annual, 67700 E7-23247 Centers Centers for Medicare & Medicaid Services RULES Medicaid: Medicaid Integrity Program; contractor liability limitations, 67653-67656 E7-23217 Medicare: Home health prospective payment system; 2008 CY refinement and rate update Correction, 67656-67663 E7-23272 Skilled nursing facilities; prospective payment system and consolidated billing; 2008 FY rates update Correction, 67652-67653 E7-23219 Commerce Commerce Department See Census Bureau See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement list; additions and deletions, 67697-67699 E7-23236 E7-23237 E7-23238 CITA Committee for the Implementation of Textile Agreements NOTICES Cotton, wool, and man-made textiles:
China, 67718-67720 E7-23303 E7-23304 Copyright Copyright Royalty Board, Library of Congress RULES Noncommercial educational broadcasting; copyrighted works use; statutory license rates and terms, 67646-67652 E7-23145 Drug Drug Enforcement Administration NOTICES *Applications, hearings, determinations, etc.:* American Custom Chemicals Corp., 67758 E7-23187 Clinical Supplies Management, Inc., 67758-67759 E7-23188 Lipomed Inc., 67759 E7-23184 Norac Inc., 67759-67760 E7-23185 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 67720 E7-23186 EPA Environmental Protection Agency NOTICES Agency information collection activities; proposals, submissions, and approvals, 67720-67722 E7-23296 Environmental statements; availability, etc.:
Agency comment availability, 67722-67723 E7-23242 Agency weekly receipts, 67723 E7-23241 Meetings: Science Advisory Board, 67723-67724 E7-23298 Scientific Counselors Board, 67724-67725 E7-23297 Executive Executive Office for Immigration Review PROPOSED RULES Immigration: Aliens; voluntary departure review, 67674-67687 E7-23289 Executive Executive Office of the President See Presidential Documents FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives: Air Tractor, Inc., 67687-67690 E7-23229 FCC Federal Communications Commission RULES Radio stations; table of assignments:
Colorado, 67667-67668 E7-23299 E7-23301 Nebraska, 67668 E7-23302 Federal Emergency Federal Emergency Management Agency RULES Flood elevation determinations: Various States, 67663-67667 E7-23214 PROPOSED RULES Flood elevation determinations: Oklahoma; correction, 67690-67691 E7-23215 NOTICES Meetings: National Advisory Council, 67743-67744 E7-23216 Federal Highway Federal Highway Administration NOTICES Environmental statements; notice of intent: Christian County et al., IL, 67779 07-5881 Federal Motor Federal Motor Carrier Safety Administration NOTICES Motor carrier safety standards:
Exemption applications— Verigo, Inc., 67779-67781 E7-23245 Federal Railroad Federal Railroad Administration NOTICES Exemption petitions, etc.: Mount Vernon Terminal Railway, Inc., 67781 E7-23199 SMS Lines, 67781-67782 E7-23200 Traffic control systems; discontinuance or modification: R.J. Corman Railroad, 67782 E7-23201 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Change in bank control, 67725 E7-23178 Formations, acquisitions, and mergers, 67725-67726 E7-23179 FTC Federal Trade Commission NOTICES Prohibited trade practices:
Budget Rent-A-Car System, Inc., 67726-67727 E7-23293 Schering-Plough Corp., 67727-67729 E7-23291 Fish Fish and Wildlife Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 67745-67747 E7-23197 Meetings: Sport Fishing and Boating Partnership Council, 67747 E7-23345 Food Food and Drug Administration RULES Human Drugs: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products (OTC)— Antitussive drug products; technical amendment, 67639-67640 E7-23207 Medical devices:
Hematology and pathology devices— Automated blood cell separator device operating by centrifugal separation principle; reclassification, 67640-67644 E7-23285 NOTICES Agency information collection activities; proposals, submissions, and approvals, 67733-67735 E7-23275 Meetings: Food labeling; symbol usage to communicate nutrition information, 67735 E7-23211 Reports and guidance documents; availability, etc.: Automated blood cell separator device; Class II special controls, 67736 E7-23281 Forest Forest Service NOTICES Recreation fee areas:
Rio Grande National Forest, CO; overnight rental fees, 67696 E7-23196 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health NOTICES Meetings: National Biodefense Science Board, 67729-67730 07-5885 Vital and Health Statistics National Committee, 67730 07-5876 Reports and guidance documents; availability, etc.: National Toxicology Program, Center for Evaluation of Risks to Human Reproduction— Bisphenol A; expert panel report, 67730-67731 E7-23234 Public Readiness and Emergency Preparedness Act— Pandemic countermeasures; declaration, 67731-67732 07-5884 Homeland Homeland Security Department See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Grants and cooperative agreements; availability, etc.:
Homeless assistance; excess and surplus Federal properties, 67744 E7-23082 Industry Industry and Security Bureau RULES Export Administration regulations: Legal authority citations updates, 67636-67639 E7-23249 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Reclamation Bureau NOTICES Committees; establishment, renewal, termination, etc.: Invasive Species Advisory Committee, 67744-67745 E7-23213 International International Boundary and Water Commission, United States and Mexico NOTICES Environmental statements; availability, etc.:
Hidalgo, Cameron, and Willacy Counties, TX; Lower Rio Grande Flood Control Project, 67754-67756 E7-23029 International International Trade Administration NOTICES Antidumping: Glycine from— China, 67701 E7-23284 Hand trucks and parts from— China, 67701 E7-23288 Honey from— China, 67702-67703 E7-23287 Countervailing duties: Light-walled rectangular pipe and tube from— China, 67703-67711 E7-23283 Export trade certificates of review, 67711-67712 E7-23286 International International Trade Commission NOTICES Import investigations:
Polyethylene terephthalate film, sheet, and strip from— Various countries, 67756 E7-23223 U.S.-Israel agricultural trade; probable economic effects on U.S. and Israeli agricultural industries, 67756-67757 E7-23224 Wireless communication chips and chipsets, and products containing same, including wireless handsets and network interface cards, 67758 E7-23220 Justice Justice Department See Drug Enforcement Administration See Executive Office for Immigration Review See Justice Programs Office Justice Justice Programs Office NOTICES Meetings:
Public Safety Officer Medal of Valor Review Board, 67760 E7-23240 Labor Labor Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 67760-67761 E7-23027 Land Land Management Bureau NOTICES Realty actions; sales, leases, etc.: Colorado, 67747-67748 E7-23228 Resource management plans, etc.: Ely Field Office, NV, 67748-67750 E7-23190 Library Library of Congress See Copyright Royalty Board, Library of Congress Mexico Mexico and United States, International Boundary and Water Commission See International Boundary and Water Commission, United States and Mexico NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 67736-67738 E7-23183 E7-23235 Inventions, Government-owned; availability for licensing, 67738-67741 E7-23193 E7-23194 Meetings:
National Human Genome Research Institute, 67741-67742 07-5883 National Institute of Allergy and Infectious Diseases, 67742-67743 07-5882 National Institute of General Medical Sciences, 67742 07-5879 National Institute on Drug Abuse, 67742 07-5878 Scientific Review Center, 67743 07-5877 Patent licenses; non-exclusive, exclusive, or partially exclusive: AmiKana, 67743 E7-23191 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Northeastern United States fisheries— Northeast multispecies, 67672-67673 07-5887 International fisheries regulations:
Pacific halibut— Guided recreational fishery; guideline harvest levels; correction, 67668-67672 E7-23268 PROPOSED RULES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Pacific halibut and red king crab, 67692-67695 E7-23257 Northeastern United States fisheries— Atlantic sea scallop, 67691-67692 E7-23266 NOTICES Endangered and threatened species: Shortnose sturgeon; status review, 67712-67713 E7-23258 Marine mammals: Incidental taking; authorization letters, etc.— CGGVeritas and Shell Offshore, Inc.;
U.S. Beaufort Sea, AK; on-ice marine geophysical and seismic programs; pinnipeds, 67713-67718 E7-23255 Meetings: North Pacific Fishery Management Council, 67718 E7-23206 National Park National Park Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 67750-67752 07-5889 National Science National Science Foundation NOTICES Meetings: National Science Board, 67761 E7-23212 NRCS Natural Resources Conservation Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 67696-67697 E7-23189 Nuclear Nuclear Regulatory Commission NOTICES Environmental statements; availability, etc.:
Defense Logistics Agency, Hammond Depot, Hammond, IN, 67761-67763 E7-23218 Meetings: Reactor Safeguards Advisory Committee, E7-23251 67763-67764 E7-23252 Regulatory guides; issuance, availability, and withdrawal, 67764-67765 E7-23221 Pension Pension Benefit Guaranty Corporation RULES Single-employer plans: Allocation of assets— Benefits payable in terminated plans, 67644-67645 E7-23267 Valuation of benefits and assets; expected retirement, 67645-67646 E7-23270 NOTICES Employee Retirement Income Security Act:
Pension plan termination insurance program; flat premium rates, 67765 E7-23269 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 67782-67784 E7-23244 Presidential Presidential Documents EXECUTIVE ORDERS National Railroad Passenger Corporation and certain labor organizations; establishment of emergency board to investigate labor disputes (EO 13452), 67825-67829 07-5919 Reclamation Reclamation Bureau NOTICES Contract negotiations:
Water service, repayment, and other water-related contract negotiations; quarterly status report, 67752-67754 E7-23230 SEC Securities and Exchange Commission PROPOSED RULES Securities: Registered open-end management investment companies; enhanced disclosure and new prospectus delivery option, 67790-67824 07-5852 NOTICES Agency information collection activities; proposals, submissions, and approvals, 67765-67767 E7-23208 E7-23209 E7-23210 Investment Company Act of 1940: John Hancock Life Insurance Co., et al., 67768-67770 E7-23205 Self-regulatory organizations; proposed rule changes:
Fixed Income Clearing Corp., 67770-67772 E7-23203 New York Stock Exchange LLC, 67772-67774 E7-23202 NYSE Arca, Inc., 67774-67776 E7-23204 Social Social Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 67776-67778 E7-23253 State State Department NOTICES Debarment proceedings: ROTHCO, 67778-67779 E7-23305 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.: Canadian Pacific Railway, 67784-67785 E7-23180 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Thrift Thrift Supervision Office NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-23263 67785-67787 E7-23264 E7-23295 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See Pipeline and Hazardous Materials Safety Administration See Surface Transportation Board Treasury Treasury Department See Thrift Supervision Office Veterans Veterans Affairs Department NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-23231 67787-67788 E7-23232 E7-23233 Separate Parts In This Issue Part II Securities and Exchange Commission, 67790-67824 07-5852 Part III Executive Office of the President, Presidential Documents, 67825-67829 07-5919 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 230 Friday, November 30, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. 03-002-6] RIN 0579-AC51 Importation of Nursery Stock; Technical Amendment AGENCY:
Animal and Plant Health Inspection Service, USDA. ACTION: Final rule; technical amendment. SUMMARY: In a final rule that was published in the **Federal Register** on August 6, 2007, and effective on September 5, 2007, we amended the regulations governing the importation of nursery stock by making several changes, including allowing the importation of restricted articles in tissue culture medium that is not transparent or translucent. It was our intent that the amended regulations only allow the use of agar or agar-like tissue culture medium.
In this amendment, we are amending the regulation to clarify that intent. EFFECTIVE DATE: November 30, 2007. FOR FURTHER INFORMATION CONTACT: Dr. Arnold T. Tschanz, Senior Import Specialist, Commodity Import Analysis and Operations, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236;
(301)734-5306. SUPPLEMENTARY INFORMATION: Background In a final rule published in the **Federal Register** on August 6, 2007, that was effective September 5, 2007 (72 FR 43503-43524, Docket No. 03-002-3), we amended the regulations governing the importation of nursery stock by making several changes, including allowing the importation of restricted articles in tissue culture medium that is not transparent or translucent. Before the effective date of the final rule, the regulations in paragraph
(c)of § 319.37-8 had stated: “A restricted article growing solely in agar or in other transparent or translucent tissue culture medium may be imported established in such growing media.” The final rule removed the words “transparent or translucent” from this sentence. It was our intent to remove this restriction only for agar-like tissue culture media. In the proposed rule and final rule, we indicated that bacteria in a tissue culture medium that was not transparent or translucent would quickly reproduce and form a large mass that would be visible during inspection; such a bacterial mass would only be visible in agar-like tissue culture media. Before the final rule became effective, the restriction that any tissue culture media other than agar must be transparent or translucent had effectively restricted the use of tissue culture media other than agar to agar-like tissue culture media. In removing the requirement that the tissue culture media be transparent or translucent, we neglected to specify that any tissue culture media other than agar should be similar to agar if a restricted article is intended to be imported established in growing media. This has created confusion among exporters. Therefore, we are amending paragraph
(c)of § 319.37-8 to read: “A restricted article growing solely in agar or in other agar-like tissue culture medium may be imported established in such growing media.” List of Subjects for 7 CFR Part 319 Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables. Accordingly, we are amending 7 CFR part 319 as follows: PART 319—FOREIGN QUARANTINE NOTICES 1. The authority citation for part 319 continues to read as follows: Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. § 319.37-8 [Amended] 2. In § 319.37-8, paragraph
(c)is amended by adding the word “agar-like” before the word “tissue”. Done in Washington, DC, this 26th day of November 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-23282 Filed 11-29-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 78 [Docket No. APHIS 2007-0097] Brucellosis in Cattle; State and Area Classifications; Idaho AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Affirmation of interim rule as final rule. SUMMARY: We are adopting as a final rule, without change, an interim rule that amended the brucellosis regulations concerning the interstate movement of cattle by changing the classification of Idaho from Class A to Class Free. We determined that Idaho met the standards for Class Free status. The interim rule relieved certain restrictions on the interstate movement of cattle from Idaho. DATES: Effective on November 30, 2007, we are adopting as a final rule the interim rule published at 72 FR 40062-40064 on July 23, 2007. FOR FURTHER INFORMATION CONTACT: Dr. Debbi A. Donch, Senior Staff Veterinarian, Ruminant Health Programs, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231;
(301)734-5952. SUPPLEMENTARY INFORMATION: Background Brucellosis is a contagious disease affecting animals and humans, caused by bacteria of the genus *Brucella.* The brucellosis regulations, contained in 9 CFR part 78 (referred to below as the regulations), provide a system for classifying States or portions of States according to the rate of *Brucella* infection present and the general effectiveness of a brucellosis control and eradication program. The classifications are Class Free, Class A, Class B, and Class C. States or areas that do not meet the minimum standards for Class C are required to be placed under Federal quarantine. In an interim rule 1 effective and published in the **Federal Register** on July 23, 2007 (72 FR 40062-40064, Docket No. APHIS-2007-0097), we amended the regulations by changing the classification of the State of Idaho from Class A to Class Free. That action relieved certain restrictions on the interstate movement of cattle from Idaho. 1 To view the interim rule and the comment we received, go to *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0097.* Comments on the interim rule were required to be received on or before September 21, 2007. We received one comment by that date, from a private citizen. This commenter did not, however, address the action taken in the interim rule (i.e., the change in Idaho's brucellosis classification). Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule without change. This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act. Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866. List of Subjects in 9 CFR Part 78 Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and recordkeeping requirements, Transportation. PART 78—BRUCELLOSIS Accordingly, we are adopting as a final rule, without change, the interim rule that amended 9 CFR part 78 and that was published at 72 FR 40062-40064 on July 23, 2007. Done in Washington, DC, this 26th day of November 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-23254 Filed 11-29-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 745, 746, 747, 748, 750, 752, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774 [Docket No. 071114706-7725-01] RIN 0694-AE19 Updated Statements of Legal Authority for the Export Administration Regulations AGENCY: Bureau of Industry and Security, Commerce. ACTION: Final rule. SUMMARY: This rule updates the Code of Federal Regulations
(CFR)legal authority citations for the Export Administration Regulations
(EAR)to: Replace citations to the President's Notice of October 27, 2006— *Continuation of Emergency Regarding Weapons of Mass Destruction* with the President's Notice of November 8, 2007 on the same subject, replace public law citations with United States Code citations, and remove outdated citations and to add one previously omitted citation. BIS is making these changes to keep the CFR legal authority citations for the EAR current and to comply with the Office of the Federal Register policy of using United States Code citations for statutory provisions that have been encoded into the United States Code. This rule makes no changes to the text of the EAR. DATES: Effective Date: November 30, 2007. ADDRESSES: Comments concerning this rule should be sent to *publiccomments@bis.doc.gov* , fax
(202)482-3355, or to Regulatory Policy Division, Bureau of Industry and Security, Room H2705, U.S. Department of Commerce, Washington, DC 20230. Please refer to regulatory identification number
(RIN)0694-AE19 in all comments, and in the subject line of email comments. FOR FURTHER INFORMATION CONTACT: William Arvin, Regulatory Policy Division, Bureau of Industry and Security, *telephone* :
(202)482-2440. SUPPLEMENTARY INFORMATION: Background On November 14, 1994, by Executive Order 12938, the President declared a national emergency with respect to the unusual and extraordinary threat to the national security, foreign policy and economy of the United States posed by the proliferation of weapons of mass destruction. That emergency has been continued in effect by successive annual presidential notices. On November 8, 2007 the President issued a notice continuing that emergency for one year from November 14, 2007 (72 FR 63963, November 13, 2007). This rule revises the authority citations in the Code of Federal Regulations for parts 730, 734, 736, 742, 744 and 745 of the EAR to cite the notice of November 8, 2007 and to remove the citation to the President's notice of October 27, 2006 on the same topic. This rule also revises the authority citations for all parts of EAR by removing citations to Presidential notice of August 3, 2006— *Continuation of Emergency Regarding Export Control Regulations* , because that notice has been superseded by a Presidential notice of August 15, 2007 that is cited in the authority citations for each part. BIS is making the changes described in the preceding two paragraphs to keep the CFR authority citations for the EAR current. This rule replaces the citations to Sec. 901-911, Public Law 106-387 and Sec 221 Public Law 107-56 with citations to 22 U.S.C. 7201 *et seq.* and 22 U.S.C. 7210, respectively, in the authority citations for parts 730, 738, 742, 744, 746 and 774. This rule replaces the citation to Sec. 901-911, Public Law 106-387 with a citation to 22 U.S.C. 7201 *et seq.* in the authority citations for part 740. This rule removes the citation to Public Law 108-75 from the authorities citations for part 730 because that list of citations contains a citation to 22 U.S.C. 2151 note, which is the U.S.C. citation for the provisions of Public Law 108-75 that provide authority for part 730. BIS is making the changes described in this paragraph to comply with the Office of the Federal Register policy of using United States Code citations for statutory provisions that have been encoded into the United States Code. This rule adds a previously erroneously omitted citation to Executive Order 13222 to the authorities citations for part 743. This rule makes no changes to the text of the EAR. Rulemaking Requirements 1. This rule has been determined to be not significant for purposes of Executive Order 12866. 2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget
(OMB)Control Number. This rule does not involve any collection of information. 3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132. 4. The Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) are not applicable. List of Subjects 15 CFR Part 730 Administrative practice and procedure, Advisory committees, Exports, Reporting and recordkeeping requirements, Strategic and critical materials. 15 CFR Parts 732, 740, 748, 750, 752 and 758 Administrative practice and procedure, Exports, Reporting and recordkeeping requirements. 15 CFR Part 734 Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology. 15 CFR Parts 736, 738, 770 and 772 Exports. 15 CFR Part 742 Exports, Terrorism. 15 CFR Part 743 Administrative practice and procedure, Reporting and recordkeeping requirements. 15 CFR Part 744 Exports, Reporting and recordkeeping requirements, Terrorism. 15 CFR Part 745 Administrative practice and procedure, Chemicals, Exports, Foreign trade, Reporting and recordkeeping requirements. 15 CFR Part 746 and 774 Exports, Reporting and recordkeeping requirements. 15 CFR Part 747 Administrative practice and procedure, Exports, Foreign trade, Reporting and recordkeeping requirements. 15 CFR Part 754 Agricultural commodities, Exports, Forests and forest products, Horses, Petroleum, Reporting and recordkeeping requirements. 15 CFR Part 756 Administrative practice and procedure, Exports, Penalties. 15 CFR Part 760 Boycotts, Exports, Reporting and recordkeeping requirements. 15 CFR Part 762 Administrative practice and procedure, Business and industry, Confidential business information, Exports, Reporting and recordkeeping requirements. 15 CFR Part 764 Administrative practice and procedure, Exports, Law enforcement, Penalties. 15 CFR Part 766 Administrative practice and procedure, Confidential business information, Exports, Law enforcement, Penalties. 15 CFR Part 768 Administrative practice and procedure, Exports, Reporting and recordkeeping requirements, Science and technology. Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 745, 746, 747, 748, 750, 752, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774 of the EAR (15 CFR parts 700-774) are amended as follows: [PART 730—AMENDED] 1. The authority citation for 15 CFR part 730 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 22 U.S.C. 3201 *et seq.* ; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5; 22 U.S.C. 7201 *et seq.* ; 22 U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42 FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, May 13, 2004; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007); Notice of November 8, 2007, 72 FR 63963 (November 13, 2007). [PART 732—AMENDED] 2. The authority citation for 15 CFR part 732 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 734—AMENDED] 3. The authority citation for 15 CFR part 734 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007); Notice of November 8, 2007, 72 FR 63963 (November 13, 2007). [PART 736—AMENDED] 4. The authority citation for 15 CFR part 736 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, May 13, 2004; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007); Notice of November 8, 2007, 72 FR 63963 (November 13, 2007). [PART 738—AMENDED] 5. The authority citation for 15 CFR part 738 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 *et seq.* ; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5; 22 U.S.C. 7201 *et seq.* ; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 740—AMENDED] 6. The authority citation for 15 CFR part 740 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 22 U.S.C. 7201 *et seq.* ; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 742—AMENDED] 7. The authority citation for 15 CFR part 742 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 22 U.S.C. 3201 *et seq.* ; 42 U.S.C. 2139a; 22 U.S.C. 7201 *et seq.* ; 22 U.S.C. 7210; Sec 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007); Notice of November 8, 2007, 72 FR 63963 (November 13, 2007). [PART 743—AMENDED] 8. The authority citation for 15 CFR part 743 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq;* Pub. L. 106-508; 50 U.S.C. 1701 *et seq;* E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 744—AMENDED] 9. The authority citation for 15 CFR part 744 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 22 U.S.C. 3201 *et seq.* ; 42 U.S.C. 2139a; 22 U.S.C. 7201 *et seq.* ; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007); Notice of November 8, 2007, 72 FR 63963 (November 13, 2007). [PART 745—AMENDED] 10. The authority citation for 15 CFR part 745 is revised to read as follows: Authority: 50 U.S.C. 1701 *et seq.* ; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; Notice of October 27, 2006, 71 FR 64109 (October 31, 2006). [PART 746—AMENDED] 11. The authority citation for 15 CFR part 746 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 22 U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C. 6004; 22 U.S.C. 7201 *et seq.* ; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003; Presidential Determination 2007-7 of December 7, 2006, 72 FR 1899 (January 16, 2007); Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 747—AMENDED] 12. The authority citation for 15 CFR part 747 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; Sec 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 748—AMENDED] 13. The authority citation for 15 CFR part 748 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 750—AMENDED] 14. The authority citation for 15 CFR part 750 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; Sec 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 752—AMENDED] 15. The authority citation for 15 CFR part 752 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 754—AMENDED] 16. The authority citation for 15 CFR part 754 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 30 U.S.C. 185(s), 185(u); 42 U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 466c; E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 756—AMENDED] 17. The authority citation for 15 CFR part 756 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 758—AMENDED] 18. The authority citation for 15 CFR part 758 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 760—AMENDED] 19. The authority citation for 15 CFR part 760 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 762—AMENDED] 20. The authority citation for 15 CFR part 762 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 764—AMENDED] 21. The authority citation for 15 CFR part 764 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 766—AMENDED] 22. The authority citation for 15 CFR part 766 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 768—AMENDED] 23. The authority citation for 15 CFR part 768 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 770—AMENDED] 24. The authority citation for 15 CFR part 770 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 772—AMENDED] 25. The authority citation for 15 CFR part 772 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). [PART 774—AMENDED] 26. The authority citation for 15 CFR part 774 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 *et seq.* , 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5; 22 U.S.C. 7201 *et seq.* ; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007). Dated: November 26, 2007. Matthew S. Borman, Deputy Assistant Secretary for Export Administration. [FR Doc. E7-23249 Filed 11-29-07; 8:45 am] BILLING CODE 3510-33-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 310 and 369 [Docket No. 1976N-0052T (formerly Docket No. 76N-052T)] RIN 0910-AF33 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Rule for Over-the-Counter Antitussive Drug Products; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule, technical amendment. SUMMARY: The Food and Drug Administration
(FDA)is amending its regulations (exemption for certain drugs limited by new-drug applications to prescription sale, and warning and caution statements required by regulations for drugs) by removing the entries for carbetapentane citrate. This action is associated with FDA's determination that carbetapentane citrate has not been shown to be effective at the over-the-counter
(OTC)doses stated in the exempting regulation. FDA made this determination in 1987 as part of its ongoing review of OTC drug products. DATES: This rule is effective November 30, 2007. FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993, 301-796-2090. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of September 13, 1957 (22 FR 7315), FDA proposed to exempt carbetapentane citrate preparations from the prescription-dispensing requirements of section 503(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (formerly 21 U.S.C. 353(b)(1)(C); currently 21 U.S.C. 353(b)(1)(B)). FDA stated: • Evidence now available through investigation and marketing experience shows that drug products containing this ingredient can be safely used by the laity in self-medication if they are used in accordance with the proposed labeling and • The restriction to prescription sale is no longer necessary for the protection of the public health. FDA did not receive any comments on this proposal and published a final order (final rule) in the **Federal Register** of November 1, 1957 (22 FR 8812). FDA amended § 130.102 (21 CFR 130.102) by adding new paragraph (a)(20) with marketing conditions for OTC drug products containing carbetapentane citrate labeled for the temporary relief of cough. FDA subsequently recodified § 130.102(a)(20) as § 310.201(a)(20) (21 CFR 310.201(a)(20)). As part of FDA's OTC drug review, the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (the Panel) evaluated carbetapentane citrate and found it safe but lacking adequate effectiveness data for OTC antitussive use (41 FR 38312 at 38345, September 9, 1976). In the tentative final monograph for OTC antitussive drug products (48 FR 48576 at 48580, October 19, 1983), one comment objected to the Panel's effectiveness determination. FDA responded that it agreed with the Panel's conclusions that the data were insufficient to establish effectiveness. FDA did not receive any additional effectiveness data on carbetapentane citrate. In the final rule for OTC antitussive drug products (52 FR 30042, August 12, 1987), FDA classified carbetapentane citrate as nonmonograph (not generally recognized as safe and effective) for OTC antitussive use. II. The Technical Amendment Because carbetapentane citrate had not been shown to be effective at the OTC dosages stated in § 310.201(a)(20), FDA should have removed that paragraph from § 310.201 in 1987. The current final rule corrects that oversight by removing paragraph (a)(20) from § 310.201 and reserving paragraph (a)(20) for future use. In addition, the entry for “CARBETAPENTANE CITRATE PREPARATIONS” in § 369.21 (21 CFR 369.21) states: “(See Cough-Due-to-Cold Preparations.)” The entry for “‘COUGH-DUE-TO-COLD’ PREPARATIONS” entry states: “(CARBETAPENTANE CITRATE). (See § 310.201(a)(20) of this chapter.) ‘Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.’” Both of those entries also should have been removed in 1987, and the current final rule removes them. III. Analysis of Impacts FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 * et seq. * ). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any 1 year by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation). FDA has determined that this final rule is consistent with the principles set out in Executive Order 12866 and in these two statutes. The final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. As explained later in this document, the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for this final rule, because the rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $127 million using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. The purpose of this final rule is to remove the exemption in § 310.201(a)(20) for carbetapentane citrate from the prescription-dispensing requirements of section 503(b)(1)(B) of the act and to remove two entries for carbetapentane citrate in § 369.21. FDA has reviewed its Drug Listing System and determined that there currently are no marketed OTC drug products that contain carbetapentane citrate. Therefore, FDA certifies that this final rule will not have a significant economic impact on a substantial number of small entities. No further analysis is required under the Regulatory Flexibility Act (5 U.S.C. 605(b)). IV. Paperwork Reduction Act of 1995 This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V. Environmental Impact FDA has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VI. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that this rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Any effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government occurred in 1987 when FDA classified carbetapentane citrate as not generally recognized as safe and effective for OTC antitussive use. States had the opportunity to comment at the time that final rule was published (52 FR 30042, August 12, 1987). Accordingly, FDA has concluded that this rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. List of Subjects 21 CFR Part 310 Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 369 Labeling, Medical devices, Over-the-counter drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 310 and 369 are amended as follows: PART 310—NEW DRUGS 1. The authority citation for 21 CFR part 310 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n. § 310.201 [Amended] 2. In § 310.201 remove and reserve paragraph (a)(20). PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE 3. The authority citation for 21 CFR part 369 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371. § 369.21 [Amended] 4. In § 369.21 remove the following entries: “CARBETAPENTANE CITRATE PREPARATIONS. (See Cough-Due-to-Cold Preparations.)” “‘COUGH-DUE-TO-COLD’PREPARATIONS (CARBETAPENTANE CITRATE). (See § 310.201(a)(20) of this chapter.) ‘Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.’” Dated: November 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-23207 Filed 11-29-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 864 [Docket No. 2005N-0017] Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle. DATES: This rule is effective December 31, 2007. The reclassification date is November 30, 2007. FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM-17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 *et seq.* ), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act
(SMDA)(Public Law 101-629), the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115), and the Medical Device User Fee and Modernization Act (Public Law 107-250) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are as follows: • Class I (general controls), • Class II (special controls), and • Class III (premarket approval). Under the 1976 amendments, class II devices were defined as devices for which there was insufficient information to show that general controls themselves would provide reasonable assurance of safety and effectiveness, but for which there was sufficient information to establish performance standards to provide such assurance. SMDA broadened the definition of class II devices to mean those devices for which the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, post-market surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendment devices, are classified after FDA: 1. Receives a recommendation from a device classification panel (an FDA advisory committee); 2. Publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and 3. Publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures. 1. Devices that were not in commercial distribution before May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) (21 U.S.C. 360c(f)) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless and until FDA reclassifies the device into class I or class II. 2. FDA issues an order classifying the device into class I or II in accordance with new section 513(f)(2) of the act, as amended by FDAMA; or 3. FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). A preamendments device that has been classified into class III may be marketed through premarket notification procedures, without submission of a premarket approval application
(PMA)until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval. Section 513(e) of the act governs reclassification of classified preamendments devices. This section provides that FDA may, by rulemaking, reclassify a device (in a proceeding that parallels the initial classification proceeding) based upon “new information.” FDA can initiate a reclassification under section 513(e) or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e)(1) of the act, includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., *Holland Rantos* v. *United States Department of Health, Education, and Welfare* , 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); *Upjohn* v. *Finch* , 422 F.2d 944 (6th Cir. 1970); *Bell* v. *Goddard* , 366 F.2d 177 (7th Cir. 1966)). Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see *Bell* v. *Goddard* , supra, 366 F.2d at 181; *Ethicon, Inc.* v. *FDA* , 762 F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See *Upjohn* v. *Finch* , supra, 422 F.2d at 951). Regardless of whether data before the agency are past or new data, the “new information” to support reclassification under section 513(e)(1) of the act must be “valid scientific evidence,” as defined in section 513(a)(3) of the act and 21 CFR 860.7(c)(2). (See, e.g., *General Medical Co.* v. *FDA* , 770 F.2d 214 (D.C. Cir. 1985); *Contact Lens Assoc.* v. *FDA* , 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the valid scientific evidence upon which FDA relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA. (See section 520(c) of the act (21 U.S.C. 360j(c)). Section 510(m) of the act (21 U.S.C. 360(m)) provides that FDA exempt a class II device from the premarket notification requirements under section 510(k) of the act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA believes that an automated blood cell separator device operating by centrifugal separation principle should not be exempt from premarket notification under section 510(m) of the act because premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. II. Regulatory History of the Device The automated blood cell separator device operating by centrifugal separation principle intended for the routine collection of blood and blood components is a preamendments device classified into class III. In the **Federal Register** of March 10, 2005 (70 FR 11887), based on new information with respect to the device, FDA proposed, on its own initiative, to reclassify from class III to class II the automated blood cell separator device operating by centrifugal separation principle, when the intended use of the device is for the routine collection of blood and blood components. Interested persons were invited to comment on the proposed rule by June 8, 2005. FDA received one comment on the proposed rule and draft guidance and that comment was considered as the rule and guidance were finalized. Also, FDA is correcting a regulatory citation in the proposed rule of March 10, 2005 (70 FR 11887), on page 11892, in the first column, starting in the second line; “21 CFR 803.50(b)(2)” is corrected to read “21 CFR 803.50(b)(3))”. FDA also identified the draft guidance entitled “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” as the proposed special controls capable of providing reasonable assurance of safety and effectiveness for these devices. III. Summary of Final Rule Under section 513(e) of the act and § 860.130 (21 CFR 860.130), based on new information and on its own initiative, FDA is reclassifying from class III to class II (special controls) the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. The special controls in conjunction with general controls will provide reasonable assurance of the safety and effectiveness of the device. For all other uses, including therapeutic apheresis, the device remains in its current classification as class III. All therapeutic apheresis (blood cell separator) devices are regulated by the Center for Devices and Radiological Health and are not part of § 864.9245 (21 CFR 864.9245). The automated blood cell separator device operating by centrifugal separation principle is assigned the generic name, automated blood cell separator. It is identified as a device that automatically withdraws whole blood from a donor, separates the blood into components, retains one or more components, and returns the remainder of the blood to the donor. This final rule removes reference in § 864.9245, to the words that were in parentheses, specifically, red blood cells, white blood cells, plasma, and platelets. The components obtained are transfused or used for further manufacturing. The separation bowls of centrifugal blood cell separators may be reusable or disposable, as specified by the device manufacturer. Also in this rule, we are removing from § 864.9245(b), the list of special controls for the class II automated blood cell separator device operating by filtration separation principle and intended for the routine collection of blood and blood components. The special controls guidance entitled “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle” will provide the special controls for both filtration- and centrifugal-based automated blood cell separator devices intended for the routine collection of blood and blood components. The availability of this guidance is announced elsewhere in this issue of the **Federal Register** . The special controls guidance document recommends that the manufacturer file with FDA for 3 consecutive years an annual report on the anniversary date of the final rule for reclassification or on the anniversary date of 510(k) clearance. Each annual report should include, at a minimum, the following information: • A summary of anticipated and unanticipated donor adverse events that have occurred and that are not required to be reported by manufacturers under part 803 (21 CFR part 803) Medical Device Reporting (MDR); • Any subsequent change to the device requiring the submission of a premarket notification in accordance with section 510(k) of the act; • Any subsequent change to the preamendments class III device requiring a 30-day notice in accordance with § 814.39(f) (21 CFR 814.39(f)). For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, the type of device is not exempt from premarket notification requirements. Prior to marketing the device, persons must submit to FDA a premarket notification containing information about the automated blood cell separator device they intend to market. Following the effective date of this final rule, any firm submitting a 510(k) premarket notification for an automated blood cell separator device operating by filtration or centrifugal separation principle and intended for the routine collection of blood and blood components will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness. IV. Analysis of Comments on the Proposed Rule and FDA's Response FDA received one comment on the proposed rule. The comment supported the reclassification of the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. In addition, the comment provided specific questions about the reporting requirements in the special controls guidance document and asked FDA to clarify these reporting requirements. We first provide a general response to the comment and then respond to the questions submitted in the comment. To make it easier to identify the questions provided in the comment and our responses, the word “Comment,” in parentheses, will appear before the description of the question, and the word “Response,” in parentheses, will appear before our response. We numbered the comments to distinguish the questions. When the device is reclassified, all manufacturers of currently marketed automated blood cell separators operating by centrifugal separation principle not approved under the premarket approval process should file annual reports for 3 consecutive years on the anniversary date of reclassification of the device from class III to class II, or on the anniversary date of the 510(k) clearance. Within the 3-year reporting period, any subsequent change to the device requiring a 510(k) should be included in the annual report. The criteria for reporting changes to the device and its labeling under 510(k) are delineated in FDA's guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. However, manufacturers of automated blood cell separator devices operating by filtration separation principle that were classified into class II (68 FR 9530, February 28, 2003) were subject to the special controls of § 864.9245 issued in 2003, requiring 3 consecutive years of submitting annual reports. These devices are not required to initiate another cycle of annual reports as a result of the change of special controls for those devices codified by this rule. Under §§ 606.160(b)(1)(iii) and 606.170 (21 CFR 606.160(b)(1)(iii) and 606.170), the facility using the device to collect blood and blood components is required to keep records of donor adverse reaction complaints and reports, including results of all investigations and followup. Under § 803.50(b)(3), manufacturers are responsible for conducting an investigation of each event and evaluating the cause of the event. The special controls would have the manufacturer summarize this information and submit it to FDA in the annual report. Specific questions submitted in the comment and FDA's responses: (Comment 1) Do you intend to request 3-year annual reporting only for the initial 510(k) clearance for the automated blood cell separator device? (Response) Yes. The 3-year annual reporting described in the special controls guidance document recommends annual reporting only for the initial 510(k) clearance. Any subsequent change to the device within this 3-year reporting period requiring the submission of a premarket notification in accordance with section 510(k) of the act should be included in the annual report. However, the submission of this 510(k) information concerning a change to the device would not restart the 3-year reporting period. (Comment 2) Is it correct that for a device originally approved under the PMA process, then switched to a 510(k), annual reporting would not be required? (Response) Yes, this is correct, if an automated blood cell separator device intended for the routine collection of blood and blood components was originally approved under the PMA process. (Comment 3) Does this reporting requirement apply to all automated blood cell separator devices operating by centrifugal or filtration separation principle intended for the routine collection of blood and blood components regardless of when the original clearance was granted? Would any preamendments devices be “grandfathered” in so that the reporting would not be required? (Response) The reporting recommended in the special controls guidance applies to currently marketed products not approved under the PMA process. The 3-year annual reporting for these products should begin on the anniversary date of the device reclassification from class III to class II, or, on the anniversary date of 510(k) clearance. In this rulemaking, we are reclassifying the automated blood cell separator device operating by centrifugal separation principle from class III to class II. Therefore, the reclassification date from class III to class II for the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components is the date of publication in the **Federal Register** of this final rule (see DATES ). The reclassification date from class III to class II for the automated blood cell separator device operating by filtration separation principle and intended for the routine collection of blood and blood components is February 28, 2003. Devices in commercial distribution before May 28, 1976, are also referred to as preamendments devices. On September 12, 1980 (45 FR 60643), FDA issued a final rule classifying these preamendment automated blood cell separator devices as class III (premarket approval). The 1976 amendments did not immediately subject preamendment devices classified in class III to the preamendment process. In the regulation (§ 864.9245), FDA did not set a deadline for the submission of premarket approval applications for the device. That regulation is amended in this rulemaking to reclassify the device from class III to class II. Therefore, preamendments devices are subject to this rulemaking, and the special controls guidance document as of the anniversary date of device reclassification from class III to class II. V. FDA's Conclusion Therefore, under section 513 of the act, FDA is adopting the summary of reasons for the Panel's recommendation and the summary of data upon which the Panel's recommendation is based (70 FR 11887 at 11890). FDA is also adopting the risks to public health stated in the proposed rule (70 FR 11887 at 11891). Furthermore, FDA is issuing a final rule that revises § 864.9245, thereby, reclassifying the generic type of device, automated blood cell separator operated by centrifugal separation principle and intended for the routine collection of blood and blood components from class III into class II. VI. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The reclassification of automated blood cell separator devices from class III to class II will relieve manufacturers of the cost of complying with the premarket approval requirements in section 515 of the act. Although the special controls guidance document recommends that manufacturers of these devices file with FDA an annual report for 3 consecutive years, this is less burdensome than the current premarket approval requirements, including the submission of periodic reports (21 CFR 814.84). By eliminating the need for premarket approval applications, reclassification will reduce regulatory costs with respect to these devices, impose no significant economic impact on any small entities, and may permit small potential competitors to enter the marketplace by lowering their costs. The agency therefore certifies that this final rule will not have a significant impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. VII. Environmental Impact The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IX. Paperwork Reduction Act of 1995 This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995
(PRA)is not required. FDA concludes that the special controls guidance document contains information collection provisions that are subject to review and clearance by OMB under the PRA. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal of Filtration Separation Principle.” The notice contains an analysis of the paperwork burden for the guidance. List of Subjects in 21 CFR Part 864 Blood, Medical devices, Packaging and containers. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 864 is amended as follows: PART 864—HEMATOLOGY AND PATHOLOGY DEVICES 1. The authority citation for 21 CFR part 864 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Section 864.9245 is revised to read as follows: § 864.9245 Automated blood cell separator.
(a)*Identification* . An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
(b)*Classification* . Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.” Dated: November 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-23285 Filed 11-29-07; 8:45 am] BILLING CODE 4160-01-S PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4022 Benefits Payable in Terminated Single-Employer Plans AGENCY: Pension Benefit Guaranty Corporation. ACTION: Final rule. SUMMARY: This rule amends Appendix D to the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans by adding the maximum guaranteeable pension benefit that may be paid by the PBGC with respect to a plan participant in a single-employer pension plan that terminates in 2008. The amendment is necessary because the maximum guarantee amount changes each year, based on changes in the contribution and benefit base under section 230 of the Social Security Act. The effect of the amendment is to advise plan administrators, participants and beneficiaries of the increased maximum guarantee amount for 2008. DATES: *Effective Date:* January 1, 2008. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion, Manager, Regulatory and Policy Division, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.) SUPPLEMENTARY INFORMATION: Section 4022(b) of the Employee Retirement Income Security Act of 1974 provides for certain limitations on benefits guaranteed by the PBGC in terminating single-employer pension plans covered under Title IV of ERISA. One of the limitations, set forth in section 4022(b)(3)(B), is a dollar ceiling on the amount of the monthly benefit that may be paid to a plan participant (in the form of a life annuity beginning at age 65) by the PBGC. The ceiling is equal to “$750 multiplied by a fraction, the numerator of which is the contribution and benefit base (determined under section 230 of the Social Security Act) in effect at the time the plan terminates and the denominator of which is such contribution and benefit base in effect in calendar year 1974 [$13,200].” This formula is also set forth in § 4022.22(b) of the PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022). Appendix D to part 4022 lists, for each year beginning with 1974, the maximum guaranteeable benefit payable by the PBGC to participants in single-employer plans that have terminated in that year. Section 230(d) of the Social Security Act (42 U.S.C. 430(d)) provides special rules for determining the contribution and benefit base for purposes of ERISA section 4022(b)(3)(B). Each year the Social Security Administration determines, and notifies the PBGC of, the contribution and benefit base to be used by the PBGC under these provisions, and the PBGC publishes an amendment to Appendix D to part 4022 to add the guarantee limit for the coming year. The PBGC has been notified by the Social Security Administration that, under section 230 of the Social Security Act, $75,900 is the contribution and benefit base that is to be used to calculate the PBGC maximum guaranteeable benefit for 2008. Accordingly, the formula under section 4022(b)(3)(B) of ERISA and 29 CFR 4022.22(b) is: $750 multiplied by $75,900/$13,200. Thus, the maximum monthly benefit guaranteeable by the PBGC in 2008 is $4,312.50 per month in the form of a life annuity beginning at age 65. This amendment updates Appendix D to part 4022 to add this maximum guaranteeable amount for plans that terminate in 2008. (If a benefit is payable in a different form or begins at a different age, the maximum guaranteeable amount is the actuarial equivalent of $4,312.50 per month.) General notice of proposed rulemaking is unnecessary. The maximum guaranteeable benefit is determined according to the formula in section 4022(b)(3)(B) of ERISA, and these amendments make no change in its method of calculation but simply list 2008 maximum guaranteeable benefit amounts for the information of the public. The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866. Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)). List of Subjects in 29 CFR Part 4022 Pension insurance, Pensions, Reporting and recordkeeping requirements. In consideration of the foregoing, 29 CFR part 4022 is amended as follows: PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS 1. The authority citation for part 4022 continues to read as follows: Authority: 29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344. 2. Appendix D to part 4022 is amended by adding a new entry to the end of the table to read as follows. The introductory text is reproduced for the convenience of the reader and remains unchanged. Appendix D to Part 4022—Maximum Guaranteeable Monthly Benefit The following table lists by year the maximum guaranteeable monthly benefit payable in the form of a life annuity commencing at age 65 as described by § 4022.22(b) to a participant in a plan that terminated in that year: Year Maximum guaranteeable monthly benefit * * * * * 2008 $4,312.50 Issued in Washington, DC, this 27th day of November, 2007. Vincent K. Snowbarger, Deputy Director, Pension Benefit Guaranty Corporation. [FR Doc. E7-23267 Filed 11-29-07; 8:45 am] BILLING CODE 7709-01-P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4044 Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age AGENCY: Pension Benefit Guaranty Corporation. ACTION: Final rule. SUMMARY: This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table that applies to any plan being terminated either in a distress termination or involuntarily by the PBGC with a valuation date falling in 2008, and is used to determine expected retirement ages for plan participants. This table is needed in order to compute the value of early retirement benefits and, thus, the total value of benefits under the plan. DATES: *Effective Date:* January 1, 2008. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion, Manager, Regulatory and Policy Division, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.) SUPPLEMENTARY INFORMATION: The PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) sets forth (in subpart B) the methods for valuing plan benefits of terminating single-employer plans covered under Title IV of the Employee Retirement Income Security Act of 1974. Under ERISA section 4041(c), guaranteed benefits and benefit liabilities under a plan that is undergoing a distress termination must be valued in accordance with part 4044, subpart B. In addition, when the PBGC terminates an underfunded plan involuntarily pursuant to ERISA Section 4042(a), it uses the subpart B valuation rules to determine the amount of the plan's underfunding. Under § 4044.51(b) of the asset allocation regulation, early retirement benefits are valued based on the annuity starting date, if a retirement date has been selected, or the expected retirement age, if the annuity starting date is not known on the valuation date. Sections 4044.55 through 4044.57 set forth rules for determining the expected retirement ages for plan participants entitled to early retirement benefits. Appendix D of part 4044 contains tables to be used in determining the expected early retirement ages. Table I in appendix D (Selection of Retirement Rate Category) is used to determine whether a participant has a low, medium, or high probability of retiring early. The determination is based on the year a participant would reach “unreduced retirement age” ( *i.e.* , the earlier of the normal retirement age or the age at which an unreduced benefit is first payable) and the participant's monthly benefit at unreduced retirement age. The table applies only to plans with valuation dates in the current year and is updated annually by the PBGC to reflect changes in the cost of living, etc. Tables II-A, II-B, and II-C (Expected Retirement Ages for Individuals in the Low, Medium, and High Categories respectively) are used to determine the expected retirement age after the probability of early retirement has been determined using Table I. These tables establish, by probability category, the expected retirement age based on both the earliest age a participant could retire under the plan and the unreduced retirement age. This expected retirement age is used to compute the value of the early retirement benefit and, thus, the total value of benefits under the plan. This document amends appendix D to replace Table I-07 with Table I-08 in order to provide an updated correlation, appropriate for calendar year 2008, between the amount of a participant's benefit and the probability that the participant will elect early retirement. Table I-08 will be used to value benefits in plans with valuation dates during calendar year 2008. The PBGC has determined that notice of and public comment on this rule are impracticable and contrary to the public interest. Plan administrators need to be able to estimate accurately the value of plan benefits as early as possible before initiating the termination process. For that purpose, if a plan has a valuation date in 2008, the plan administrator needs the updated table being promulgated in this rule. Accordingly, the public interest is best served by issuing this table expeditiously, without an opportunity for notice and comment, to allow as much time as possible to estimate the value of plan benefits with the proper table for plans with valuation dates in early 2008. The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866. Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)). List of Subjects in 29 CFR Part 4044 Pension insurance, Pensions. In consideration of the foregoing, 29 CFR part 4044 is amended as follows: PART 4044—[AMENDED] 1. The authority citation for part 4044 continues to read as follows: Authority: 29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362. 2. Appendix D to part 4044 is amended by removing Table I-07 and adding in its place Table I-08 to read as follows: Appendix D to Part 4044—Tables Used to Determine Expected Retirement Age TABLE I-08.—Selection of Retirement Rate Category [(For Plans with valuation dates after December 31, 2007, and before January 1, 2009)] Participant reaches URA in year— Participant's Retirement Rate Category is— Low 1 if monthly benefit at URA is less than— Medium 2 if monthly benefit at URA is From To High 3 if monthly benefit at URA is greater than— 2009 536 536 2,264 2,264 2010 549 549 2,320 2,320 2011 563 563 2,376 2,376 2012 576 576 2,430 2,430 2013 589 589 2,486 2,486 2014 602 602 2,544 2,544 2015 616 616 2,602 2,602 2016 630 630 2,662 2,662 2017 645 645 2,723 2,723 2018 or later 660 660 2,786 2,786 1 Table II-A. 2 Table II-B. 3 Table II-C. Issued in Washington, DC, this 27th day of November, 2007. Vincent K. Snowbarger, Deputy Director, Pension Benefit Guaranty Corporation. [FR Doc. E7-23270 Filed 11-29-07; 8:45 am] BILLING CODE 7709-01-P LIBRARY OF CONGRESS Copyright Royalty Board 37 CFR Part 381 [Docket No. 2006-2 CRB NCBRA] Noncommercial Educational Broadcasting Statutory License AGENCY: Copyright Royalty Board, Library of Congress. ACTION: Final rule. SUMMARY: The Copyright Royalty Judges are publishing final regulations setting the royalty rates and terms under the Copyright Act for the noncommercial educational broadcasting statutory license for the license period 2008-2012. DATES: *Effective Date:* January 1, 2008. *Applicability Date:* The regulations apply to the license period January 1, 2008 through December 31, 2012. FOR FURTHER INFORMATION CONTACT: Richard Strasser, Senior Attorney, or Gina Giuffreda, Attorney-Advisor, by telephone at
(202)707-7658 or e-mail at *crb@loc.gov.* SUPPLEMENTARY INFORMATION: Background Section 118 of the Copyright Act, title 17 of the United States Code, establishes a statutory license for the use of certain copyrighted works in connection with noncommercial television and radio broadcasting. The terms and rates for this statutory license have been adjusted periodically by the Librarian of Congress and appear in 37 CFR part 253. However, the Copyright Royalty and Distribution Reform Act of 2004, Pub. L. 108-419, transferred jurisdiction over these rates and terms to the Copyright Royalty Judges (“Judges”). 17 U.S.C. 801(b)(1). This is a window year for the establishment of new rates and terms for the 2008-2012 license period. On January 9, 2006, pursuant to 17 U.S.C. 803(b)(1)(A)(i)(V), the Copyright Royalty Judges published a notice in the **Federal Register** announcing the commencement of proceedings under 17 U.S.C. 118 and requesting interested parties to submit their petitions to participate. 71 FR 1453 (January 9, 2006). Petitions to participate were received from: The American Council on Education (“ACE”); the National Music Publishers Association, Inc. (“NMPA”); the Harry Fox Agency (“HFA”); the National Religious Broadcasters Noncommercial Music License Committee (“NRBNMLC”); Royalty Logic, Inc., the American Society of Composers, Authors and Publishers (“ASCAP”); Broadcast Music, Inc. (“BMI”); SESAC, Inc.; National Public Radio (“NPR”); the Corporation for Public Broadcasting (“CPB”); the Public Broadcasting Service (“PBS”); and the Church Music Publishers Association. The Judges set the timetable for the three-month negotiation period, see 17 U.S.C. 803(b)(3), and directed the participants to submit their written direct statements no later than January 20, 2007. Instead of written direct statements, the parties submitted notification of settlements and proposed rates and terms for the Judges to adopt. Section 801(b)(7)(A) allows for the adoption of rates and terms negotiated by “some or all of the participants in a proceeding at any time during the proceeding” provided they are submitted to the Copyright Royalty Judges for approval. This section provides that in such event:
(i)The Copyright Royalty Judges shall provide to those that would be bound by the terms, rates, or other determination set by any agreement in a proceeding to determine royalty rates an opportunity to comment on the agreement and shall provide to participants in the proceeding under section 803(b)(2) that would be bound by the terms, rates, or other determination set by the agreement to comment on the agreement and object to its adoption as a basis for statutory terms and rates; and
(ii)the Copyright Royalty Judges may decline to adopt the agreement as a basis for statutory terms and rates for participants that are not parties to the agreement, if any participant described in clause
(i)objects to the agreement and the Copyright Royalty Judges conclude, based on the record before them if one exists, that the agreement does not provide a reasonable basis for setting statutory terms or rates. 17 U.S.C. 801(b)(7)(A). Accordingly, on April 17, 2007, the Judges published a Notice of Proposed Rulemaking (“NPRM”) requesting comment on the proposed rates and terms, with certain modifications, submitted to the Judges as part of a joint proposal by the following parties: ACE, ASCAP, BMI, HFA, NMPA, NPR, NRBNMLC, PBS, and SESAC. 72 FR 19138 (April 17, 2007). Comments were due by May 17, 2007. In response to the NPRM, the Judges received only one comment, which was jointly submitted by NPR and PBS, stating that there had been an inadvertent error in the joint proposal with respect to some of the NPR and PBS proposed royalty rates, thereby making the rates proposed in § 381.7(b)(1)(i) incorrect. Comments of NPR and PBS, filed May 15, 2007, at 2. They then set out the intended rates. *Id.* Consequently, as required by section 801(b)(7)(A), the Judges published a second NPRM requesting comment on the rates correcting those previously proposed in § 381.7(b)(1)(i). 72 FR 54623 (September 26, 2007) and 72 FR 57101 (October 5, 2007). Comments were due by October 26, 2007. In response to this NPRM, the Judges received one comment from the organization Students for a Democratic Society. The comment stated that “in some cases these royalties might be restrictive” and that royalties may be paid “for something that (perhaps) is in fact Fair Use.” Comment submitted by Students for a Democratic Society on September 26, 2007. However, there was no indication that this organization would be bound by the proposed rates and terms or that it was prepared to participate in further proceedings to establish rates and terms for the section 118 license. Having received no objections from a party that would be bound by the proposed rates and terms and that would be willing to participate in further proceedings, the Copyright Royalty Judges, by this notice, are adopting final regulations which set the rates and terms for the section 118 statutory license for the period 2008-2012. Cost of Living Adjustment The regulations adopted today require that on December 1 of each year, starting with 2007, the Judges publish a notice of the change in the cost of living as determined by the Consumer Price Index (all consumers, all items) during the period from the most recent Index published prior to the previous notice, 1 to the most recent Index published prior to December 1 of that year. 37 CFR 381.10(a). The regulations also require the Judges to publish a revised schedule of rates for the public performance of musical compositions in the ASCAP, BMI, and SESAC repertoires by public broadcasting entities licensed to colleges and universities, reflecting the change in the Consumer Price Index. 37 CFR 381.10(b). However, the rate for SESAC set forth in § 381.5(c)(4) is the rate, without any adjustment, to be paid to SESAC for calendar year 2008. This rate will be subject to an annual cost of living adjustment each year thereafter for calendar years 2009 through 2012. *See* Joint Proposal of SESAC, Inc. and the American Council of Education at 2 (filed January 26, 2007). Therefore, the Copyright Royalty Judges are announcing the change in the Consumer Price Index and performing the required cost of living adjustment only to the rates for ASCAP and BMI set out in §§ 381.5(c)(1) and (c)(2) in the April 17 NPRM. *See* 72 FR 19140. 1 The last cost of living adjustment was published on December 1, 2006. *See* 71 FR 69486. The change in the cost of living as determined by the Consumer Price Index (all consumers, all items) during the period from the most recent Index published before December 1, 2006, to the most recent Index published before December 1, 2007, is 3.5% (2006's figure was 201.8; the figure for 2007 is 208.936, based on 1982-1984 = 100 as a reference base). Rounding off to the nearest dollar, the royalty rate for the use of musical compositions in each of the repertoires of ASCAP and BMI is $287. List of Subjects in 37 CFR Part 381 Copyright, Music, Radio, Television, Rates. Final Regulations For the reasons set forth in the preamble, the Copyright Royalty Judges are adding Part 381 to Chapter III of title 37 of the Code of Federal Regulations to read as follows: PART 381—USE OF CERTAIN COPYRIGHTED WORKS IN CONNECTION WITH NONCOMMERCIAL EDUCATIONAL BROADCASTING Sec. 381.1 General. 381.2 Definition of public broadcasting entity. 381.3 [Reserved] 381.4 Performance of musical compositions by PBS, NPR, and other public broadcasting entities engaged in the activities set forth in 17 U.S.C. 118(c). 381.5 Performance of musical compositions by public broadcasting entities licensed to colleges and universities. 381.6 Performance of musical compositions by other public broadcasting entities. 381.7 Recording rights, rates and terms. 381.8 Terms and rates of royalty payments for the use of published pictorial, graphic, and sculptural works. 381.9 Unknown copyright owners. 381.10 Cost of living adjustment. 381.11 Notice of restrictions on use of reproductions of transmission programs. Authority: 17 U.S.C. 118, 801(b)(1) and 803. § 381.1 General. This part establishes terms and rates of royalty payments for certain activities using published nondramatic musical works and published pictorial, graphic and sculptural works during a period beginning on January 1, 2008, and ending on December 31, 2012. Upon compliance with 17 U.S.C. 118, and the terms and rates of this part, a public broadcasting entity may engage in the activities with respect to such works set forth in 17 U.S.C. 118(c). § 381.2 Definition of public broadcasting entity. As used in this part, the term *public broadcasting entity* means a noncommercial educational broadcast station as defined in section 397 of title 47 and any nonprofit institution or organization engaged in the activities described in 17 U.S.C. 118(c). § 381.3 [Reserved] § 381.4 Performance of musical compositions by PBS, NPR and other public broadcasting entities engaged in the activities set forth in 17 U.S.C. 118(c). The following schedule of rates and terms shall apply to the performance by PBS, NPR and other public broadcasting entities engaged in activities set forth in 17 U.S.C. 118(c) of copyrighted published nondramatic musical compositions, except for public broadcasting entities covered by §§ 381.5 and 381.6, and except for compositions which are the subject of voluntary license agreements.
(a)*Determination of royalty rate.*
(1)For performance of such work in a feature presentation of PBS: 2008-2012 $227.58
(2)For performance of such a work as background or theme music in a PBS program: 2008-2012 $57.66
(3)For performance of such a work in a feature presentation of a station of PBS: 2008-2012 $19.45
(4)For performance of such a work as background or theme music in a program of a station of PBS: 2008-2012 $4.10
(5)For the performance of such a work in a feature presentation of NPR: 2008-2012 $23.07
(6)For the performance of such a work as background or theme music in an NPR program: 2008-2012 $5.59
(7)For the performance of such a work in a feature presentation of a station of NPR: 2008-2012 $1.63
(8)For the performance of such a work as background or theme music in a program of a station of NPR: 2008-2012 $.58
(9)For purposes of this schedule the rate for the performance of theme music in an entire series shall be double the single program theme rate.
(10)In the event the work is first performed in a program of a station of PBS or NPR, and such program is subsequently distributed by PBS or NPR, an additional royalty payment shall be made equal to the difference between the rate specified in this section for a program of a station of PBS or NPR, respectively, and the rate specified in this section for a PBS or NPR program, respectively.
(b)*Payment of royalty rate.* The required royalty rate shall be paid to each known copyright owner not later than July 31 of each calendar year for uses during the first six months of that calendar year, and not later than January 31 for uses during the last six months of the preceding calendar year.
(c)*Records of use.* PBS and NPR shall, upon the request of a copyright owner of a published musical work who believes a musical composition of such owner has been performed under the terms of this schedule, permit such copyright owner a reasonable opportunity to examine their standard cue sheets listing the nondramatic performances of musical compositions on PBS and NPR programs. Any local PBS and NPR station that shall be required by the provisions of any voluntary license agreement with ASCAP, BMI or SESAC covering the license period January 1, 2008, to December 31, 2012, to provide a music use report shall, upon request of a copyright owner who believes a musical composition of such owner has been performed under the terms of this schedule, permit such copyright owner to examine the report.
(d)*Terms of use.* The fees provided in this schedule for the performance of a musical work in a program shall cover performances of such work in such program for a period of four years following the first performance. § 381.5 Performance of musical compositions by public broadcasting entities licensed to colleges and universities.
(a)*Scope.* This section applies to the performance of copyrighted published nondramatic musical compositions by noncommercial radio stations which are licensed to accredited colleges, accredited universities, or other accredited nonprofit educational institutions and which are not affiliated with National Public Radio. For purposes of this section, accreditation of institutions providing post-secondary education shall be determined by a regional or national accrediting agency recognized by the Council for Higher Education Accreditation or the United States Department of Education; and accreditation of institutions providing elementary or secondary education shall be as recognized by the applicable state licensing authority.
(b)*Voluntary license agreements.* Notwithstanding the schedule of rates and terms established in this section, the rates and terms of any license agreements entered into by copyright owners and colleges, universities, and other nonprofit educational institutions concerning the performance of copyrighted musical compositions, including performances by noncommercial radio stations, shall apply in lieu of the rates and terms of this section.
(c)*Royalty rate.* A public broadcasting entity within the scope of this section may perform published nondramatic musical compositions subject to the following schedule of royalty rates:
(1)For all such compositions in the repertory of ASCAP, $287 annually.
(2)For all such compositions in the repertory of BMI, $287 annually.
(3)For all such compositions in the repertory of SESAC, $116 annually.
(4)For the performance of any other such compositions: $1.
(d)*Payment of royalty rate.* The public broadcasting entity shall pay the required royalty rate to ASCAP, BMI and SESAC not later than January 31 of each year.
(e)*Records of use.* A public broadcasting entity subject to this section shall furnish to ASCAP, BMI and SESAC, upon request, a music-use report during one week of each calendar year. ASCAP, BMI and SESAC shall not in any one calendar year request more than 10 stations to furnish such reports. § 381.6 Performance of musical compositions by other public broadcasting entities.
(a)*Scope.* This section applies to the performance of copyrighted published nondramatic musical compositions by radio stations not licensed to colleges, universities, or other nonprofit educational institutions and which are not affiliated with NPR. In the event that a station owned by a public broadcasting entity broadcasts programming by means of an in-band, on-channel (“IBOC”) digital radio signal and such programming is different than the station's analog broadcast programming, then any such programming shall be deemed to be provided by a separate station requiring a separate royalty payment.
(b)*Voluntary license agreements.* Notwithstanding the schedule of rates and terms established in this section, the rates and terms of any license agreements entered into by copyright owners and noncommercial radio stations within the scope of this section concerning the performance of copyrighted musical compositions, including performances by noncommercial radio stations, shall apply in lieu of the rates and terms of this section.
(c)*Royalty rate.* A public broadcasting entity within the scope of this section may perform published nondramatic musical compositions subject to the following schedule of royalty rates:
(1)For all such compositions in the repertory of ASCAP, the royalty rates shall be as follows: Population count 2008 2009 2010 2011 2012 Level 1 0-249,999 $ 550 $ 567 $ 583 $ 601 $ 619 Level 2 250,000-499,999 1,000 1,030 1,061 1,093 1,126 Level 3 500,000-999,999 1,500 1,545 1,591 1,639 1,688 Level 4 1,000,000-1,499,999 2,000 2,060 2,122 2,185 2,251 Level 5 1,500,000-1,999,999 2,500 2,575 2,652 2,732 2,814 Level 6 2,000,000-2,499,999 3,000 3,090 3,183 3,278 3,377 Level 7 2,500,000-2,999,999 3,500 3,605 3,713 3,825 3,939 Level 8 3,000,000 and above 5,000 5,150 5,305 5,464 5,628
(2)For all such compositions in the repertory of BMI, the royalty rates shall be as follows: Population count 2008 2009 2010 2011 2012 Level 1 0-249,999 $ 550 $ 567 $ 583 $ 601 $ 619 Level 2 250,000-499,999 1,000 1,030 1,061 1,093 1,126 Level 3 500,000-999,999 1,500 1,545 1,591 1,639 1,688 Level 4 1,000,000-1,499,999 2,000 2,060 2,122 2,185 2,251 Level 5 1,500,000-1,999,999 2,500 2,575 2,652 2,732 2,814 Level 6 2,000,000-2,499,999 3,000 3,090 3,183 3,278 3,377 Level 7 2,500,000-2,999,999 3,500 3,605 3,713 3,825 3,939 Level 8 3,000,000 and above 5,000 5,150 5,305 5,464 5,628
(3)For all such compositions in the repertory of SESAC, the royalty rates shall be as follows: Population count 2008 2009 2010 2011 2012 Level 1 0-249,999 $ 120 $ 124 $ 127 $ 131 $ 135 Level 2 250,000-499,999 200 206 212 219 225 Level 3 500,000-999,999 300 309 318 328 338 Level 4 1,000,000-1,499,999 400 412 424 437 450 Level 5 1,500,000-1,999,999 500 515 530 546 563 Level 6 2,000,000-2,499,999 600 618 637 656 675 Level 7 2,500,000-2,999,999 700 721 743 765 788 Level 8 3,000,000 and above 1,000 1,030 1,061 1,093 1,126
(4)For the performance of any other such compositions, in 2008 through 2012, $1.
(d)*Payment of royalty rate.* The public broadcasting entity shall pay the required royalty rate to ASCAP, BMI and SESAC not later than January 31 of each year. Each annual payment shall be accompanied by a signed declaration stating the Population Count of the public broadcasting entity and the source for such Population Count. An exact copy of such declaration shall be furnished to each of ASCAP, BMI and SESAC. Upon prior written notice thereof from ASCAP, BMI or SESAC, a public broadcasting entity shall make its books and records relating to its Population Count available for inspection.
(e)*Records of use.* A public broadcasting entity subject to this section shall furnish to ASCAP, BMI and SESAC, upon request, a music-use report during one week of each calendar year. ASCAP, BMI and SESAC each shall not in any one calendar year request more than 10 stations to furnish such reports.
(f)*Definitions.* As used in paragraphs
(c)and
(d)of this section, the following terms and their variant forms mean the following:
(1)*Population Count.* The combination of:
(i)The number of persons estimated to reside within a stations Predicted 60 dBu Contour, based on the most recent available census data; and
(ii)The nonduplicative number of persons estimated to reside in the Predicted 60 dBu Contour of any Translator Station or Booster Station that extends a public broadcasting entity's signal beyond the contours of a station's Predicted 60 dBu Contour.
(iii)In determining Population Count, a station or a Translator Station or a Booster Station may use and report the total population data, from a research company generally recognized in the broadcasting industry, for the radio market within which the station's community license is located.
(2)*Predicted 60 dBu Contour* shall be calculated as set forth in 47 CFR 73.313.
(3)*Translator Station and Booster Station* shall have the same meanings as set forth in 47 CFR 74.1201. § 381.7 Recording rights, rates and terms.
(a)*Scope.* This section establishes rates and terms for the recording of nondramatic performances and displays of musical works, other than compositions subject to voluntary license agreements, on and for the radio and television programs of public broadcasting entities, whether or not in synchronization or timed relationship with the visual or aural content, and for the making, reproduction, and distribution of copies and phonorecords of public broadcasting programs containing such nondramatic performances and displays of musical works solely for the purpose of transmission by public broadcasting entities. The rates and terms established in this schedule include the making of the reproductions described in 17 U.S.C. 118(c)(3).
(b)*Royalty rate.* (1)(i) For uses described in paragraph
(a)of this section of a musical work in a PBS-distributed program, the royalty fees shall be calculated by multiplying the following per-composition rates by the number of different compositions in that PBS-distributed program: 2008-2012
(A)Feature $114.09
(B)Concert feature (per minute) 34.26
(C)Background 57.66
(D)Theme: *(1)* Single program or first series program 57.66 *(2)* Other series program 23.41
(ii)For such uses other than in a PBS-distributed television program, the royalty fee shall be calculated by multiplying the following per-composition rates by the number of different compositions in that program: 2008-2012
(A)Feature $9.43
(B)Concert feature (per minute) 2.48
(C)Background 4.10
(D)Theme: ( *1* ) Single program or first series of program 4.10 ( *2* ) Other series program 1.63
(iii)In the event the work is first recorded other than in a PBS-distributed program, and such program is subsequently distributed by PBS, an additional royalty payment shall be made equal to the difference between the rate specified in this section for other than a PBS-distributed program and the rate specified in this section for a PBS-distributed program.
(2)For uses licensed herein of a musical work in a NPR program, the royalty fees shall be calculated by multiplying the following per-composition rates by the number of different compositions in any NPR program distributed by NPR. For purposes of this schedule “National Public Radio” programs include all programs produced in whole or in part by NPR, or by any NPR station or organization under contract with NPR. 2008-2012
(i)Feature $12.35
(ii)Concert feature (per minute) 18.13
(iii)Background 6.19
(iv)Theme:
(A)Single program or first series program 6.19
(B)Other series program 2.47
(3)For purposes of this schedule, a “Concert Feature” shall be deemed to be the nondramatic presentation in a program of all or part of a symphony, concerto, or other serious work originally written for concert performance, or the nondramatic presentation in a program of portions of a serious work originally written for opera performance.
(4)For such uses other than in an NPR-produced radio program: 2008-2012
(i)Feature $.79
(ii)Feature (concert) (per half hour) 1.65
(iii)Background .40
(5)The schedule of fees covers use for a period of three years following the first use. Succeeding use periods will require the following additional payment: Additional one-year period—25 percent of the initial three-year fee; second three-year period—50 percent of the initial three-year fee; each three-year fee thereafter—25 percent of the initial three-year fee; provided that a 100 percent additional payment prior to the expiration of the first three-year period will cover use during all subsequent use periods without limitation. Such succeeding uses which are subsequent to December 31, 2012, shall be subject to the royalty rates established in this schedule.
(c)*Payment of royalty rates* . The required royalty rates shall be paid to each known copyright owner not later than July 31 of each calendar year for uses during the first six months of that calendar year, and not later than January 31 for uses during the last six months of the preceding calendar year.
(d)*Records of use* —(1) *Maintenance of cue sheets* . PBS and its stations, NPR, or other public broadcasting entities shall maintain and make available for examination pursuant to paragraph
(e)of this section copies of their standard cue sheets or summaries of same listing the recording of the musical works of such copyright owners.
(2)*Content of cue sheets or summaries* . Such cue sheets or summaries shall include:
(i)The title, composer and author to the extent such information is reasonably obtainable.
(ii)The type of use and manner of performance thereof in each case.
(iii)For Concert Feature music, the actual recorded time period on the program, plus all distribution and broadcast information available to the public broadcasting entity.
(e)*Filing of use reports with the Copyright Royalty Judges. Deposit of cue sheets or summaries* . PBS and its stations, NPR, or other television public broadcasting entity shall deposit with the Copyright Royalty Judges one electronic copy in Portable Document Format
(PDF)on compact disk (an optical data storage medium such as a CD-ROM, CD-R or CD-RW) or floppy diskette of their standard music cue sheets or summaries of same listing the recording pursuant to this schedule of the musical works of copyright owners. Such cue sheets or summaries shall be deposited not later than July 31 of each calendar year for recordings during the first six months of the calendar year and not later than January 31 of each calendar year for recordings during the second six months of the preceding calendar year. PBS and NPR shall maintain at their offices copies of all standard music cue sheets from which such music use reports are prepared. Such music cue sheets shall be furnished to the Copyright Royalty Judges upon their request and also shall be available during regular business hours at the offices of PBS or NPR for examination by a copyright owner who believes a musical composition of such owner has been recorded pursuant to this schedule. § 381.8 Terms and rates of royalty payments for the use of published pictorial, graphic, and sculptural works.
(a)*Scope* . This section establishes rates and terms for the use of published pictorial, graphic, and sculptural works by public broadcasting entities for the activities described in 17 U.S.C. 118. The rates and terms established in this schedule include the making of the reproductions described in 17 U.S.C. 118(c).
(b)*Royalty rate* .
(1)The following schedule of rates shall apply to the use of works within the scope of this section:
(i)For such uses in a PBS-distributed program: 2008-2012
(A)For featured display of a work $69.70
(B)For background and montage display 33.99
(C)For use of a work for program identification or for thematic use 137.40
(D)For the display of an art reproduction copyrighted separately from the work of fine art from which the work was reproduced irrespective of whether the reproduced work of fine art is copyrighted so as to be subject also to payment of a display fee under the terms of the schedule 45.14
(ii)For such uses in other than PBS-distributed programs: 2008-2012
(A)For featured display of a work $45.14
(B)For background and montage display 23.13
(C)For use of a work for program identification or for thematic use 92.27
(D)For the display of an art reproduction copyrighted separately from the work of fine art from which the work was reproduced irrespective of whether the reproduced work of fine art is copyrighted so as to be subject also to payment of a display fee under the terms of this schedule 23.14
(2)For the purposes of the schedule in paragraph (b)(1) of this section the rate for the thematic use of a work in an entire series shall be double the single program theme rate. In the event the work is first used other than in a PBS-distributed program, and such program is subsequently distributed by PBS, an additional royalty payment shall be made equal to the difference between the rate specified in this section for other than a PBS-distributed program and the rate specified in this section for a PBS-distributed program.
(3)“Featured display” for purposes of this schedule means a full-screen or substantially full-screen display appearing on the screen for more than three seconds. Any display less than full-screen or substantially full-screen, or full-screen for three seconds or less, is deemed to be a “background or montage display”.
(4)“Thematic use” is the utilization of the works of one or more artists where the works constitute the central theme of the program or convey a story line.
(5)“Display of an art reproduction copyrighted separately from the work of fine art from which the work was reproduced” means a transparency or other reproduction of an underlying work of fine art.
(c)*Payment of royalty rate* . PBS or other public broadcasting entity shall pay the required royalty fees to each copyright owner not later than July 31 of each calendar year for uses during the first six months of that calendar year, and not later than January 31 for uses during the last six months of the preceding calendar year.
(d)*Records of use* .
(1)PBS and its stations or other public broadcasting entity shall maintain and furnish either to copyright owners, or to the offices of generally recognized organizations representing the copyright owners of pictorial, graphic and sculptural works, copies of their standard lists containing the pictorial, graphic, and sculptural works displayed on their programs. Such notice shall include the name of the copyright owner, if known, the specific source from which the work was taken, a description of the work used, the title of the program on which the work was used, and the date of the original broadcast of the program.
(2)Such listings shall be furnished not later than July 31 of each calendar year for displays during the first six months of the calendar year, and not later than January 31 of each calendar year for displays during the second six months of the preceding calendar year.
(e)*Filing of use reports with the Copyright Royalty Judges* .
(1)PBS and its stations or other public broadcasting entity shall deposit with the Copyright Royalty Judges one electronic copy in Portable Document Format
(PDF)on compact disk (an optical data storage medium such as a CD-ROM, CD-R or CD-RW) or floppy diskette of their standard lists containing the pictorial, graphic, and sculptural works displayed on their programs. Such notice shall include the name of the copyright owner, if known, the specific source from which the work was taken, a description of the work used, the title of the program on which the work was used, and the date of the original broadcast of the program.
(2)Such listings shall be furnished not later than July 31 of each calendar year for displays during the first six months of the calendar year, and not later than January 31 of each calendar year for displays during the second six months of the preceding calendar year.
(f)*Terms of use* .
(1)The rates of this schedule are for unlimited use for a period of three years from the date of the first use of the work under this schedule. Succeeding use periods will require the following additional payment: Additional one-year period—25 percent of the initial three-year fee; second three-year period—50 percent of the initial three-year fee; each three-year period thereafter—25 percent of the initial three-year fee; provided that a 100 percent additional payment prior to the expiration of the first three-year period will cover use during all subsequent use periods without limitation. Such succeeding uses which are subsequent to December 31, 2012, shall be subject to the rates established in this schedule.
(2)Pursuant to the provisions of 17 U.S.C. 118(e), nothing in this schedule shall be construed to permit, beyond the limits of fair use as provided in 17 U.S.C. 107, the production of a transmission program drawn to any substantial extent from a published compilation of pictorial, graphic, or sculptural works. § 381.9 Unknown copyright owners. If PBS and its stations, NPR and its stations, or other public broadcasting entity is not aware of the identity of, or unable to locate, a copyright owner who is entitled to receive a royalty payment under this part, they shall retain the required fee in a segregated trust account for a period of three years from the date of the required payment. No claim to such royalty fees shall be valid after the expiration of the three-year period. Public broadcasting entities may establish a joint trust fund for the purposes of this section. Public broadcasting entities shall make available to the Copyright Royalty Judges, upon request, information concerning fees deposited in trust funds. § 381.10 Cost of living adjustment.
(a)On or before December 1, 2007, the Copyright Royalty Judges shall publish in the **Federal Register** a notice of the change in the cost of living as determined by the Consumer Price Index (all consumers, all items) during the period from the most recent Index published prior to December 1, 2006, to the most recent Index published prior to December 1, 2007. On each December 1 thereafter the Copyright Royalty Judges shall publish a notice of the change in the cost of living during the period from the most recent index published prior to the previous notice, to the most recent Index published prior to December 1, of that year.
(b)On the same date of the notices published pursuant to paragraph
(a)of this section, the Copyright Royalty Judges shall publish in the **Federal Register** a revised schedule of rates for § 381.5 which shall adjust those royalty amounts established in dollar amounts according to the change in the cost of living determined as provided in paragraph
(a)of this section. Such royalty rates shall be fixed at the nearest dollar.
(c)The adjusted schedule for rates for § 381.5 shall become effective thirty days after publication in the **Federal Register** . § 381.11 Notice of restrictions on use of reproductions of transmission programs. Any public broadcasting entity which, pursuant to 17 U.S.C. 118, supplies a reproduction of a transmission program to governmental bodies or nonprofit institutions shall include with each copy of the reproduction a warning notice stating in substance that the reproductions may be used for a period of not more than seven days from the specified date of transmission, that the reproductions must be destroyed by the user before or at the end of such period, and that a failure to fully comply with these terms shall subject the body or institution to the remedies for infringement of copyright. Dated: November 23, 2007. James Scott Sledge, Chief Copyright Royalty Judge. [FR Doc. E7-23145 Filed 11-29-07; 8:45 am] BILLING CODE 1410-72-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 409 [CMS-1545-CN2] RIN 0938-AM46 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule; correction notice. SUMMARY: This document corrects technical errors that appeared in the August 3, 2007 **Federal Register** , entitled “Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2008; Final Rule.” DATES: *Effective Date:* This correction is effective January 1, 2008. FOR FURTHER INFORMATION CONTACT: Bill Ullman,
(410)786-5667. SUPPLEMENTARY INFORMATION: I. Background On September 28, 2007, we published a correction notice (FR Doc. E7-18732, 72 FR 55085) to correct a number of technical errors that appeared in the FY 2008 Skilled Nursing Facility Prospective Payment System (SNF PPS) final rule on August 3, 2007 (FR Doc. 07-3784, 72 FR 43412). In this notice, we are correcting certain technical errors in the wage index values, which have been recently identified. Specifically, we have determined that in the process of developing the most recent hospital wage index, an inpatient hospital provider was inadvertently assigned to the wrong Core-Based Statistical Area (CBSA). This provider was incorrectly located in CBSA 16180 (Carson City, NV) instead of CBSA 39900 (Reno-Sparks, NV). Accordingly, we are revising the wage index values for CBSA 16180 Carson City, NV from 0.9353 to the corrected value of 1.0003. Similarly, we are revising the wage index value for CBSA 39900 Reno-Sparks, NV from 1.0959 to the corrected value of 1.0715. As we are revising the entries for only these two particular CBSAs, we are not republishing the lengthy Table 8, “FY 2008 Wage Index for Urban Areas Based on CBSA Labor market Areas,” in its entirety in this notice. We note that the corrected version of this table is available online on the SNF PPS website, at *http://www.cms.hhs.gov/SNFPPS/04_WageIndex.asp* . The corrections in this document appear below in the “Correction of Errors” section. The provisions in this correction notice are effective as of January 1, 2008. II. Correction of Errors In FR Doc. 07-3784 (72 FR 43412), make the following corrections: 1. On page 43441, in column 3 (“Wage Index”) of Table 8, “Wage Index for Urban Areas Based on CBSA Labor Market Areas”, the entry “0.9353” for CBSA 16180 Carson City, NV is corrected to read “1.0003”. 2. On page 43455, in column 3 (“Wage Index”) of Table 8, “Wage Index for Urban Areas Based on CBSA Labor Market Areas”, the entry “1.0959” for CBSA 39900 Reno-Sparks, NV is corrected to read “1.0715”. III. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the **Federal Register** to provide a period for public comment before the provisions of a notice take effect in accordance with section 553(b) of the Administrative Procedure Act
(APA)(5 U.S.C. 553(b)). However, we can waive the notice and comment procedure if the Secretary finds, for good cause, that a notice and comment process is impracticable, unnecessary or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice. We find for good cause that it is unnecessary to undertake notice and comment rulemaking because this notice merely provides technical corrections to the regulations. We are not making substantive changes to our payment methodologies or policies, but rather, are simply implementing correctly the payment methodologies and policies that we previously proposed, received comment on, and subsequently finalized. The public has already had the opportunity to comment on these payment methodologies and policies, and this correction notice is intended solely to ensure that the FY 2008 SNF PPS final rule accurately reflects them. Therefore, we believe that undertaking further notice and comment procedures to incorporate these corrections into the update notice is unnecessary and contrary to the public interest. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 19, 2007. Ann C. Agnew, Executive Secretary to the Department. [FR Doc. E7-23219 Filed 11-29-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 455 [CMS-2264-F] RIN 0938-AO88 Medicaid Integrity Program; Limitation on Contractor Liability AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: The Medicaid Integrity Program (the Program) provides that the Secretary promote the integrity of the Medicaid program by entering into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide for limitations on a contractor's liability while performing these services under the Program. The final rule will, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 (Limitation on Liability) of the Social Security Act. DATES: *Effective Date:* These regulations are effective on December 31, 2007. FOR FURTHER INFORMATION CONTACT: Barbara Rufo, 410-786-5589 or Crystal High, 410-786-8366. SUPPLEMENTARY INFORMATION: I. Background A. Current Law States and the Federal Government share in the responsibility for safeguarding Medicaid program integrity. States must comply with Federal requirements designed to ensure that Medicaid funds are properly spent (or recovered, when necessary). The Centers for Medicare & Medicaid Services
(CMS)is the primary Federal agency responsible for providing oversight of States' activities and facilitating their program integrity efforts. B. Medicaid Integrity Program Section 6034 of the Deficit Reduction Act
(DRA)of 2005 (Pub. L. 109-171, enacted on February 8, 2006) amended title XIX of the Social Security Act (the Act), (42 U.S.C. 1396 *et seq.* ) by redesignating the old section 1936 as section 1937; and inserting the new section 1936 to combat Medicaid fraud and abuse. For the first time, the Program authorizes the Federal Government to directly identify, recover, and prevent inappropriate Medicaid payments. It will also support the efforts of the State Medicaid agencies through a combination of oversight and technical assistance. Although individual States work to ensure the integrity of their respective Medicaid programs, the Program represents CMS' first comprehensive national strategy to detect and prevent Medicaid fraud and abuse. The Program will provide CMS with the ability to more directly ensure the accuracy of Medicaid payments and to deter those who would exploit the program. The new section 1936 of the Act states that the Secretary shall promote the integrity of the Medicaid program by entering into contracts with eligible entities to carry out the following activities: 1. Review of the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk or other basis) for which payment may be made under a State plan approved under title XIX (or under any waiver of this plan approved under section 1115 of the Act) to determine whether fraud, waste, and/or abuse has occurred, or is likely to occur, or whether these actions have any potential for resulting in an expenditure of funds under title XIX in a manner that is not intended under the provisions of title XIX. 2. Audit of claims for payment for items or services furnished, or administrative services rendered, under a State plan under title XIX, including cost reports, consulting contracts; and risk contracts under section 1903(m) of the Act. 3. Identification of overpayments to individuals or entities receiving Federal funds under title XIX. 4. Education of providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. Section 1936 of the Act also provides that the Secretary will, by regulation, provide for the limitation of a contractor's liability for actions taken to carry out a contract under the Medicaid Integrity Program. II. Provisions of the Proposed Regulation and Response to Comments Limitations on Contractor Liability Section 6034 of the Deficit Reduction Act of 2005 amended title XIX of the Act by establishing, under the new section 1936, the Medicaid Integrity Program to promote the integrity of the Medicaid program by authorizing the Centers for Medicare & Medicaid Services
(CMS)(on behalf of the Secretary) to enter into contracts with contractors that will
(1)review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act;
(2)audit claims for payment of items or services furnished, or administrative services rendered, under a State plan;
(3)identify overpayments to individuals or entities receiving Federal funds under title XIX; and
(4)educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will set forth limitations on a contractor's liability while performing these services under the Program. Contractors that perform activities under the Program will be reviewing activities of providers and others seeking Medicaid payment for providing services to Medicaid beneficiaries. In an effort to reduce or eliminate the Program contractors' exposure to possible legal action from entities they review, section 1936 of the Act requires that we, by regulation, limit the Program contractor's liability for actions taken in carrying out its contract. We must establish, to the extent we find appropriate, standards and other substantive and procedural provisions that are the same as, or comparable to, those contained in section 1157 of the Act. Section 1157 of the Act provides that any organization having a contract (under Title XI, Part B of the Act) with the Secretary, as well as its employees, fiduciaries, and anyone who furnishes professional services to such an organization, is/are protected from civil and criminal liability in performing its duties under the Act or its contract, provided these duties are performed with due care. In the July 20, 2007 **Federal Register** (72 FR 39766), we published the proposed rule entitled, “Medicaid Integrity Program; Limitation on Contractor Liability,” and provided for a 30-day public comment period. We received a total of 1 timely comment from a health care association. The comment questioned the proposed provisions and we responded with further clarification in our response. Brief summaries for each proposed provision, a summary of the public comments we received, and our responses to comments, are set forth below. General Comments *Comment:* A commenter expressed concern that CMS has not provided the health care community or the public any information about the federal government's discussions on the Program's contractors, termed Medicaid Integrity Contractor's,
(MIC)roles, responsibilities, and qualifications. The commenter also stated the MICs may not understand state-specific payment methodologies, resulting in a significant learning curve. The commenter also expressed concern that a lack of public information about the capabilities of the contractors prevents the transparency which all federal government programs should strive to achieve. *Response:* We appreciate the commenter's concerns regarding information sharing and transparency, as well as the concern that the MICs may face a significant learning curve in developing a knowledge base and experience regarding state-specific practices. To address these concerns, we have been working aggressively with our state and federal partners and stakeholders (State Medicaid Directors, State Program Integrity Directors, Medicaid Fraud Control Unit Directors, the Federal Bureau of Investigation, and HHS' Office of Inspector General) to share information and to obtain their input on our planning efforts. We have also presented information regarding both the Program and MICs at conferences of national and regional associations, including the National Association of State Medicaid Directors and the National Association for Medicaid Program Integrity. To address the MICs' potential learning curve, we have engaged strategic development contractors to help us build upon the tools and expertise we already have. These strategic contractors are assisting by developing state program integrity profiles, and developing audit protocols, methodologies, and standards for the MICs to use. These tools will establish a solid knowledge baseline for the MICs, enabling them to get off to an aggressive, well-informed start. Moreover, we strive to inform the public about our mission and accomplishments, and encourage interested parties to utilize CMS' internet site to learn more about Medicaid program integrity generally at: *http://www.cms.hhs.gov/MCAIDFraudAbuseGenInfo/* , and more specific information about the CMS' Medicaid integrity implementation plan and efforts at: *http://www.cms.hhs.gov/DeficitReductionAct/Downloads/CMIPupdateaugust2007final.pdf.* Section 455.1 Basis and Scope The proposed rule, in § 455.1, Basis and scope, added a new paragraph
(c)stating that subpart C implements section 1936 of the Act. Section 1936 of the Act establishes the Medicaid Integrity Program under which the Secretary will promote the integrity of the program by entering into contracts with eligible entities to carry out the activities under subpart C. We did not receive public comments on this provision, therefore we adopt the provision as final. Subpart C—Medicaid Integrity Program Section 455.200 Basis and Scope In § 455.200(a), we set forth the proposed statutory basis which would implement section 1936 of the Act, which states that the Secretary will promote the integrity of the Medicaid program by entering into contracts with eligible entities to carry out the activities under subpart C. In § 455.200(b) we proposed the scope for the limitation on a contractor's liability to carry out a contract under the Medicaid Integrity Program as proposed under new § 455.202. We did not receive public comments on this provision; therefore we adopt the provision as final. Section 455.202 Limitation on Contractor Liability We proposed in § 455.202 to protect Program contractors from liability in the performance of their contracts provided they carry out their contractual duties with due care. *Comment:* A commenter questioned the proposed standard for the MICs which states they will be protected from civil and criminal liability in performing their duties so long as they perform these duties with “due care.” The commenter expressed that under such a standard, the Federal Government cannot sufficiently ensure that the MICs will be held adequately accountable for their actions. *Response:* As explained in the proposed rule, we believe that the due care standard specified in § 455.202 is the only standard consistent with the statutory mandate of the Act. Section 1936 of the Act require us to limit a contractor's liability by employing the same or comparable standards and provisions as are contained in section 1157 of the Act. Section 1157 of the Act limits a contractor's liability under a due care standard. We believe that applying this standard to the MICs strikes a reasonable balance between the concerns of the contractors and those subject to the contractors' review. We further believe the MICs will operate with due care to avoid liability, and those being reviewed have the assurance that they have legal recourse if a contractor fails to abide by that standard. Alternative Standards of Liability Considered In accordance with section 1936 of the Act, we proposed to employ the same standards for payment of legal expenses as are contained in section 1157(d) of the Act. Therefore, in § 455.202(b) we proposed that we make payment to Program contractors, their members, employees, and anyone who provides legal counsel or services to them, for expenses incurred in the defense of any legal action related to the performance of the Program contract. We also proposed that any and all payment(s) and the amount of each payment(s) if any, will be determined exclusively by us, and conditioned upon
(1)the reasonableness of the expense(s);
(2)the amount of government funds available for payment(s); and
(3)whether the payment(s) is(are) allowable under the terms of the contract. In § 455.202, we considered employing a standard for the limitation of liability other than the due care standard. We considered whether it would be appropriate to provide that a contractor would not be civilly liable by reason of the performance of any duty, function, or activity under its contract provided the contractor was not grossly negligent in that performance. However, section 1936 of the Act requires that we employ the same or comparable standards and provisions as are contained in section 1157 of the Act. This approach is consistent with a similar approach taken in the Medicare Integrity Program (72 FR 48870), which has virtually identical statutory limitations on contractor liability language. Therefore, we did not believe that it would be appropriate to expand the scope of immunity to a standard of gross negligence, as it would not be a comparable standard to that set forth in section 1157(b) of the Act. III. Provisions of the Final Rule In this final rule we are adopting the provisions as set forth in the July 20, 2007 proposed rule (72 FR 39776) as final. IV. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. V. Regulatory Impact Statement We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act
(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule will not reach the economic threshold and thus is not considered a major rule. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined that this rule will not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This rule will have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation will not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in 42 CFR Part 455 Fraud, Grant programs—health, Health facilities, Health professions, Investigations, Medicaid, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below: PART 455—PROGRAM INTEGRITY; MEDICAID 1. The authority citation for part 455 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. In § 455.1, add new paragraph
(c)to read as follows: § 455.1 Basis and scope.
(c)Subpart C implements section 1936 of the Act. It establishes the Medicaid Integrity Program under which the Secretary will promote the integrity of the program by entering into contracts with eligible entities to carry out the activities of subpart C. 3. New subpart C, consisting of § 455.200 and § 455.202, is added to part 455 to read as follows: Subpart C—Medicaid Integrity Program Sec. 455.200 Basis and scope. 455.202 Limitation on contractor liability. Subpart C—Medicaid Integrity Program § 455.200 Basis and scope.
(a)*Statutory basis.* This subpart implements section 1936 of the Act that establishes the Medicaid Integrity Program under which the Secretary will promote the integrity of the program by entering into contracts with eligible entities to carry out the activities under this subpart C.
(b)*Scope.* This subpart provides for the limitation on a contractor's liability to carry out a contract under the Medicaid Integrity Program. § 455.202 Limitation on contractor liability.
(a)A program contractor, a person, or an entity employed by, or having a fiduciary relationship with, or who furnishes professional services to a program contractor will not be held to have violated any criminal law and will not be held liable in any civil action, under any law of the United States or of any State (or political subdivision thereof), by reason of the performance of any duty, function, or activity required or authorized under this subpart or under a valid contract entered into under this subpart, provided due care was exercised in that performance and the contractor has a contract with CMS under this subpart.
(b)CMS pays a contractor, a person, or an entity described in paragraph
(a)of this section, or anyone who furnishes legal counsel or services to a contractor or person, a sum equal to the reasonable amount of the expenses, as determined by CMS, incurred in connection with the defense of a suit, action, or proceeding, if the following conditions are met:
(1)The suit, action, or proceeding was brought against the contractor, person or entity by a third party and relates to the contractor's, person's or entity's performance of any duty, function, or activity under a contract entered into with CMS under this subpart.
(2)The funds are available.
(3)The expenses are otherwise allowable under the terms of the contract. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: September 27, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: October 9, 2007. Michael O. Leavitt, Secretary. [FR Doc. E7-23217 Filed 11-29-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 484 [CMS-1541-CN2] RIN 0938-AO32 Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008; Corrections AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule with comment period; correction notice. SUMMARY: This document corrects typographical and technical errors that appeared in the August 29, 2007 **Federal Register** , entitled “Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008.” EFFECTIVE DATE: This correction notice is effective January 1, 2008. FOR FURTHER INFORMATION CONTACT: Sharon Ventura,
(410)786-1985. SUPPLEMENTARY INFORMATION: I. Background FR Doc. 07-4184 of August 29, 2007 (72 FR 49762) contained several typographical and technical errors that this notice serves to identify and correct. II. Summary of Errors On page 49773, in the second paragraph of the third column, the reference to the McCall report is incomplete. We are correcting the error by providing the complete reference. In the first column on page 49774, we are clarifying and correcting an erroneous reference to certain V codes in our response to a comment. In the first full paragraph of the first column on page 49775, we inadvertently imply that a table is included in the August 29, 2007 final rule. However, the referenced table is found in the May 4, 2007 proposed rule. We are correcting this by referencing the proposed rule. On page 49780, the example in column 1 is revised to reflect the updates made to Table 2A in the final rule with comment period. On page 49789, in the fourth column of Table 2B, the Short Descriptions of ICD-9-CM codes 161, 162, 163, 164, and 165 incorrectly contain asterisks. On page 49793, in Table 2B, the ICD-9-CM code 321.8, we inadvertently did not include an ‘M’ next to it under the column titled, “Manifestation codes” in order to properly identify it as a manifestation code. To more accurately reflect ICD-9-CM coding terminology, we are correcting the Diagnostic Category titles for ICD-9-CM codes V55.0 and V55.5 on page 49817 of Table 2B. In addition we are correcting the Diagnostic Category titles for ICD-9-CM codes V55.5, V55.0, and V55.6 and the Short Descriptions for ICD-9-CM codes V55.5 and V55.0 on page 49855 of Table 10B. During production of Table 4 on pages 49826 through 49827, the decimal amounts were incorrectly rounded when computing the scaled coefficients. We are revising Table 4 to reflect the corrected rounded amounts. The average cost amounts in Table 5 on pages 49828 through 49832 were also rounded incorrectly. Therefore, we are revising Table 5 to reflect the average cost of each case-mix group. There are no changes to the relative weights in Table 5. On page 49833, second paragraph, a negative sign was inadvertently placed before “8.7 percent.” On page 49844, we incorrectly stated the acronym for the Health Insurance Prospective Payment System (HIPPS) code. The correct acronym is HIPPS. We are correcting the acronym to HIPPS wherever it appears. On page 49853 the description for Item #5 for selected skin conditions in Table 10A incorrectly includes the words “or other”. Also on page 49853, in the first column of the Note section for Table 10A, we are correcting punctuation errors. Therefore, in the second column of the Note section for Table 10A, the reference to Table 12B should refer to Table 10B. Lastly, we inadvertently excluded a footnote to Table 10A that clarified how points are awarded for ulcer related conditions. On page 49854, we are correcting the short description of ICD-9-CM code 250.8x & 707.10-707.9 from “(PRIMARY OR FIRST OTHER DIAGNOSIS = 250.8x AND PRIMARY OR FIRST OTHER DIAGNOSIS = 707.10-707.9).” to “(PRIMARY DIAGNOSIS = 250.8x AND OTHER DIAGNOSIS = 707.10-707.9).” On page 49855, we inadvertently omitted ICD-9-CM code 948 from Table 10B under the traumatic wounds, burns and post-operative complications category. We are adding code 948 and its short description to Table 10B. Table 12 and 14 contain several typographical errors. The CY 2007 per-visit amount for the speech-language pathology discipline found in the second column of both Table 12 on page 49868 and in Table 14 on page 49873 should be $121.32, and the speech-language pathology per-visit amount for CY 2008 in column 5 of Table 12 should be $124.65. Similarly, on page 49873, the speech-language pathology per-visit amount for CY 2008 in column 5 of Table 14 should be $122.23. We are correcting errors in the outlier example that begins on page 49870 and continues on page 49871 as well as providing clarifying narrative language. Due to corrections being made to the outlier example, noted below, the utilization used in the outlier example that was published in the final rule would not allow the episode to qualify for an outlier payment. Consequently, we are increasing the number of skilled nursing and home health aide visits in the corrected outlier example of this correction notice. In addition, in Step 2, on page 49871, in the calculation of the total wage-adjusted fixed dollar loss amount, the NRS amount was inadvertently included as part of the calculation. We are removing the language in Step 2 of the outlier example that incorrectly includes the NRS amount, in order to reflect the correct outlier policy. In Step 3 of the outlier example, near the bottom of the second column and the top of the third column on page 49871, we incorrectly refer to physical therapy visits as home health aide visits in three instances. In Step 4 of the outlier example, on page 49871, we incorrectly calculated the costs absorbed by the Home Health Agencies
(HHAs)in excess of the outlier threshold by subtracting only the episode payment from the HHA's imputed costs. The sum of the episode payment and the fixed dollar loss amount, which together make up the outlier threshold, should be subtracted from the imputed costs. (This is reflected in the corrected Step 4 of the outlier example in Section III Correction of Errors). On page 49877, in Table 15 under the impacts by “Type of Facility”, we are correcting a typographical error in the group name for the subtotal for voluntary non-profit HHAs. During our calculation of the hospital wage index, wage data from two inpatient hospital providers that belong in the Hartford-West Hartford-East Hartford, CT core-based statistical area
(CBSA)were inadvertently included in rural Connecticut. Accordingly, in Addendum A, we are revising the wage index value for CBSA Code 07 (rural Connecticut) from 1.1283 to 1.1711. We are also correcting the wage index value in Addendum C as well as correcting the percentage change from CY 2007 to CY 2008 for rural Connecticut to 0.02 percent. In Addendum B, we are revising the wage index value for CBSA Code 25540 (Hartford-West Hartford-East Hartford, CT) from 1.0937 to 1.0930. We are also correcting the wage index value in Addendum C as well as correcting the percentage change from CY 2007 to CY 2008 for CBSA 25540 to 0.33 percent. During our calculation of the hospital wage index, wage data from one IPPS hospital was incorrectly assigned to CBSA 16180 (Carson City, NV) and should have been assigned to CBSA 39900 (Reno-Sparks, NV). Accordingly, in Addendum B, we are revising the wage index values for CBSA Code 16180 (Carson City, NV) from 0.9353 to 1.0003 and for CBSA Code 39900 (Reno-Sparks, NV) from 1.0959 to 1.0715. We are also correcting these two wage index errors in Addendum C as well as correcting the percentage change from CY 2007 to CY 2008 for CBSA 16180 and CBSA 39900 to −0.22 percent and −10.43 percent respectively. In addition, in the footnote of Addendum A, at the end of the second sentence, we are correcting the CY that was referenced as CY 2007, instead of CY 2008. Additionally, we inadvertently left out the last two sentences which more fully describe the wage index values for Massachusetts and Puerto Rico and are correcting the footnote by adding those sentences at the end of the footnote at the bottom of Addendum A. In Addendum B, on page 49901, the reference to the footnote for CBSA 25980 was incorrectly labeled as footnote “2”, when there is only one footnote for Addendum B. Footnote 2 on page 49932 is also incorrectly labeled. Consequently, the reference to the footnote for CBSA 25980 and the actual footnote should be “1”. III. Correction of Errors In FR Doc. 07-4184 of August 29, 2007 (72 FR 49762), make the following corrections: 1. On page 49773, in the third column, in the second paragraph, in line 6, replace “(McCall *et al.* , 2003)” with “(N McCall *et al.* , “Utilization of Home Health Services before and after the Balanced Budget Act of 1997: What Were the Initial Effects?” Health Services Research, Feb. 2003:85-106.)”. 2. On page 49774, in the first column, in the fifth full paragraph, in line 8, revise “However, we have tested the non-routine supplies for stoma conditions for which we have added appropriate “status
(V44)V-codes” and “attention
(V55)V-codes” to the model.” to read “However, we have tested both the case-mix model and the non-routine supplies model for stoma conditions, and as a result we have added appropriate “attention to” V-codes (selected codes within V55) to the scoring systems”. 3. On page 49775, in the first column, in the first full paragraph, in lines 13 and 14, revise “(please see Table 2A at the end of section III.B.5)” to read “(please see Table 2A in the May 4, 2007 HH PPS proposed rule)”. 4. On page 49780, in the first column, in line 6, revise “Items 16 and 17” to read “Items 15, 16, and 17”. Also, in the first column of page 49780, in line 7, revise “both” to read “all three”. 5. On page 49789, in Table 2B, in the fourth column, in lines 3 through 7, remove the asterisk at the end of each Short Description of ICD-9-CM codes 161, 162, 163, 164, and 165. 6. On page 49793, in the third column of Table 2B, in line 6 from the bottom, insert an “M” next to the ICD-9-CM code “321.8”. 7. On page 49817, in the first column of Table 2B, “Tracheostomy care” is corrected to read “Tracheostomy”. Similarly, “Urostomy/Cystostomy care” is corrected to read “Urostomy/Cystostomy”. 8. On pages 49826 and 49827, Table 4 is corrected to read as follows: Table 4.—Regression Coefficients for Calculating Case-Mix Relative Weights Intercept (constant for all case mix groups) $1,322.92 1st and 2nd Episodes, 0 to 13 Therapy Visits C2 342.36 C3 722.64 F2 201.15 F3 391.18 S2 (6 therapy visits) 608.45 S3 (7-9 therapy visits) 1,083.40 S4 (10 therapy visits) 1,570.38 S5 (11-13 therapy visits) 1,970.41 1st and 2nd Episodes, 14 to 19 Therapy Visits Constant 2,336.39 C2 569.40 C3 1,227.33 F2 264.04 F3 429.54 S2 (16-17 therapy visits) 353.49 S3 (18-19 therapy visits) 664.75 3rd+ Episodes, 0 to 13 Therapy Visits Constant 162.55 C2 131.91 C3 648.40 F2 304.00 F3 592.10 S2 (6 therapy visits) 794.16 S3 (7-9 therapy visits) 1,253.67 S4 (10 therapy visits) 1,755.87 S5 (11-13 therapy visits) 2,152.49 3rd+ Episodes, 14 to 19 Therapy Visits Constant Constant 2,656.96 C2 623.43 C3 1,350.61 F2 297.18 F3 681.32 S2 (16-17 therapy visits) 263.13 S3 (18-19 therapy visits) 617.98 All Episodes, 20+ Therapy Visits Constant Constant 4,465.27 C2 485.17 C3 1,212.35 F2 430.23 F3 916.53 Note: Regression coefficients were scaled by a multiplier representing the ratio of the HH PS base payment level to the Abt Associates average resource cost level. 9. On pages 49828 through 49832, Table 5 is corrected to read as follows: Table 5.—Case Mix Groups, Average Cost, and Case Mix Weight Severity Level for Each Dimension Clinical Functional Service utilization Average cost Case mix weight 1st and 2nd Episodes, 0 to 13 Therapy Visits C1 F1 S1 $1,322.92 0.5827 C1 F1 S2 1,931.36 0.8507 C1 F1 S3 2,406.31 1.0599 C1 F1 S4 2,893.30 1.2744 C1 F1 S5 3,293.33 1.4506 C1 F2 S1 1,524.07 0.6713 C1 F2 S2 2,132.51 0.9393 C1 F2 S3 2,607.46 1.1485 C1 F2 S4 3,094.45 1.3630 C1 F2 S5 3,494.48 1.5392 C1 F3 S1 1,714.09 0.7550 C1 F3 S2 2,322.54 1.0230 C1 F3 S3 2,797.49 1.2322 C1 F3 S4 3,284.47 1.4467 C1 F3 S5 3,684.50 1.6229 C2 F1 S1 1,665.28 0.7335 C2 F1 S2 2,273.73 1.0015 C2 F1 S3 2,748.68 1.2107 C2 F1 S4 3,235.66 1.4252 C2 F1 S5 3,635.69 1.6014 C2 F2 S1 1,866.43 0.8221 C2 F2 S2 2,474.88 1.0901 C2 F2 S3 2,949.83 1.2993 C2 F2 S4 3,436.81 1.5138 C2 F2 S5 3,836.84 1.6900 C2 F3 S1 2,056.46 0.9058 C2 F3 S2 2,664.90 1.1738 C2 F3 S3 3,139.85 1.3830 C2 F3 S4 3,626.84 1.5975 C2 F3 S5 4,026.87 1.7737 C3 F1 S1 2,045.56 0.9010 C3 F1 S2 2,654.23 1.1691 C3 F1 S3 3,129.18 1.3783 C3 F1 S4 3,615.94 1.5927 C3 F1 S5 4,016.20 1.7690 C3 F2 S1 2,246.71 0.9896 C3 F2 S2 2,855.38 1.2577 C3 F2 S3 3,330.33 1.4669 C3 F2 S4 3,817.09 1.6813 C3 F2 S5 4,217.35 1.8576 C3 F3 S1 2,436.73 1.0733 C3 F3 S2 3,045.41 1.3414 C3 F3 S3 3,520.36 1.5506 C3 F3 S4 4,007.11 1.7650 C3 F3 S5 4,407.37 1.9413 1st and 2nd Episodes, 14 to 19 Therapy Visits C1 F1 S1 3,659.30 1.6118 C1 F1 S2 4,012.79 1.7675 C1 F1 S3 4,324.05 1.9046 C1 F2 S1 3,923.34 1.7281 C1 F2 S2 4,276.60 1.8837 C1 F2 S3 4,587.86 2.0208 C1 F3 S1 4,088.85 1.8010 C1 F3 S2 4,442.11 1.9566 C1 F3 S3 4,753.37 2.0937 C2 F1 S1 4,228.70 1.8626 C2 F1 S2 4,582.19 2.0183 C2 F1 S3 4,893.45 2.1554 C2 F2 S1 4,492.74 1.9789 C2 F2 S2 4,846.00 2.1345 C2 F2 S3 5,157.26 2.2716 C2 F3 S1 4,658.24 2.0518 C2 F3 S2 5,011.50 2.2074 C2 F3 S3 5,322.77 2.3445 C3 F1 S1 4,886.64 2.1524 C3 F1 S2 5,240.13 2.3081 C3 F1 S3 5,551.16 2.4451 C3 F2 S1 5,150.45 2.2686 C3 F2 S2 5,503.94 2.4243 C3 F2 S3 5,814.97 2.5613 C3 F3 S1 5,315.95 2.3415 C3 F3 S2 5,669.44 2.4972 C3 F3 S3 5,980.48 2.6342 3rd+ Episodes, 0 to 13 Therapy Visits C1 F1 S1 1,485.47 0.6543 C1 F1 S2 2,279.63 1.0041 C1 F1 S3 2,739.14 1.2065 C1 F1 S4 3,241.34 1.4277 C1 F1 S5 3,637.96 1.6024 C1 F2 S1 1,789.47 0.7882 C1 F2 S2 2,583.62 1.1380 C1 F2 S3 3,043.36 1.3405 C1 F2 S4 3,545.56 1.5617 C1 F2 S5 3,942.18 1.7364 C1 F3 S1 2,077.57 0.9151 C1 F3 S2 2,871.73 1.2649 C1 F3 S3 3,331.47 1.4674 C1 F3 S4 3,833.66 1.6886 C1 F3 S5 4,230.06 1.8632 C2 F1 S1 1,617.38 0.7124 C2 F1 S2 2,411.53 1.0622 C2 F1 S3 2,871.05 1.2646 C2 F1 S4 3,373.24 1.4858 C2 F1 S5 3,769.87 1.6605 C2 F2 S1 1,921.37 0.8463 C2 F2 S2 2,715.76 1.1962 C2 F2 S3 3,175.27 1.3986 C2 F2 S4 3,677.46 1.6198 C2 F2 S5 4,074.09 1.7945 C2 F3 S1 2,209.48 0.9732 C2 F3 S2 3,003.63 1.3230 C2 F3 S3 3,463.37 1.5255 C2 F3 S4 3,965.57 1.7467 C2 F3 S5 4,361.97 1.9213 C3 F1 S1 2,133.87 0.9399 C3 F1 S2 2,928.03 1.2897 C3 F1 S3 3,387.77 1.4922 C3 F1 S4 3,889.97 1.7134 C3 F1 S5 4,286.36 1.8880 C3 F2 S1 2,437.87 1.0738 C3 F2 S2 3,232.25 1.4237 C3 F2 S3 3,691.77 1.6261 C3 F2 S4 4,193.96 1.8473 C3 F2 S5 4,590.59 2.0220 C3 F3 S1 2,725.97 1.2007 C3 F3 S2 3,520.36 1.5506 C3 F3 S3 3,979.87 1.7530 C3 F3 S4 4,482.07 1.9742 C3 F3 S5 4,878.69 2.1489 3rd+ Episodes, 14 to 19 Therapy Visits C1 F1 S1 3,979.87 1.7530 C1 F1 S2 4,243.00 1.8689 C1 F1 S3 4,597.85 2.0252 C1 F2 S1 4,277.06 1.8839 C1 F2 S2 4,540.19 1.9998 C1 F2 S3 4,894.81 2.1560 C1 F3 S1 4,661.19 2.0531 C1 F3 S2 4,924.32 2.1690 C1 F3 S3 5,278.95 2.3252 C2 F1 S1 4,603.30 2.0276 C2 F1 S2 4,866.43 2.1435 C2 F1 S3 5,221.28 2.2998 C2 F2 S1 4,900.49 2.1585 C2 F2 S2 5,163.62 2.2744 C2 F2 S3 5,518.24 2.4306 C2 F3 S1 5,284.62 2.3277 C2 F3 S2 5,547.75 2.4436 C2 F3 S3 5,902.38 2.5998 C3 F1 S1 5,330.48 2.3479 C3 F1 S2 5,593.39 2.4637 C3 F1 S3 5,948.24 2.6200 C3 F2 S1 5,627.44 2.4787 C3 F2 S2 5,890.57 2.5946 C3 F2 S3 6,245.42 2.7509 C3 F3 S1 6,011.58 2.6479 C3 F3 S2 6,274.71 2.7638 C3 F3 S3 6,629.56 2.9201 All Episodes, 20+ Therapy Visits C1 F1 S1 5,788.18 2.5495 C1 F2 S1 6,218.41 2.7390 C1 F3 S1 6,704.71 2.9532 C2 F1 S1 6,273.35 2.7632 C2 F2 S1 6,703.57 2.9527 C2 F3 S1 7,189.88 3.1669 C3 F1 S1 7,000.53 3.0835 C3 F2 S1 7,430.76 3.2730 C3 F3 S1 7,917.06 3.4872 10. On page 49833, in the first column, in the second paragraph, in line 18 from the bottom, remove the “−” (minus sign) in front of “8.7 percent”. 11. On page 49844, in the first column, in the first full paragraph, in line 8, “HIHH PPS” is corrected to read “HIPPS”. Also, on page 49844, in the second column, “HIHH PPS” is corrected to read “HIPPS” in lines 2, 4, and 14. 12. On page 49853, in the second column of Table 10A, in line 5, the description for Item #5 “Primary or other diagnosis=Diabetic ulcers” is corrected to read “Primary diagnosis = Diabetic ulcers”. Also in Table 10A, add “[*]” (an asterisk enclosed in brackets) at the end of lines 5 and 10. Also on page 49853, in the first column of the “Note” for Table 10A, in line 1, replace the “,” after the word “additive” with a “;”. Also in line 1, add a “,” after the word “however”. In the second column of the “Note” for Table 10A, in line 2, “Table 12b” is corrected to read “Table 10B”. Lastly, on page 49853, add the following footnote, referenced by the “[*]” at the end of lines 5 and 10 in Table 10A, to the end of the current Note: “*If an episode receives points for diabetic ulcers, it cannot also receive points for “Non-pressure and non-stasis ulcers.” 13. On page 49854, in the fourth column of Table 10B, in lines 7 and 8, revise “(PRIMARY OR FIRST OTHER DIAGNOSIS = 250.8x AND PRIMARY OR FIRST OTHER DIAGNOSIS = 707.10-707.9).” to read “(PRIMARY DIAGNOSIS = 250.8x AND OTHER DIAGNOSIS = 707.10-707.9).” 14. On page 49855, in the second column of Table 10B, below ICD-9-cm code 946.5, insert “948”. In addition, in column 4 of Table 10B, insert the short description of ICD-9-CM code 948 directly under the short description of code 946.5. The short description for 948 should read, “BURN CLASS ACCORD-BODY SURF INVOLVED”. 15. On page 49855, in the first column of Table 10B, delete the word “Care” from the Diagnostic Category titles for ICD-9-CM codes V55.5, V55.0, and V55.6. In addition, in the fourth column of Table 10B, delete the word “CARE” from the Short Descriptions for ICD-9-CM codes V55.5 and V55.0. 16. On page 49868, in Table 12, in the second column, the CY 2007 per-visit amount “121.22” for speech-language pathology, is corrected to read “121.32”. In addition, in the fifth column, the CY 2008 per-visit amount “124.54” for speech-language pathology is corrected to read “124.65.” 17. On page 49870, on the bottom of the page, beginning in the first column, remove the language that begins with “Outlier payments are determined” through page 49871, in the third column, line 26 that ends with “episode, including the outlier payment.” Replace the previous outlier example with the following: Outlier payments are determined and calculated using the same methodology that has been used since the implementation of the HH PPS. Example 3 details the calculation of an outlier payment. Example 3. Calculation of an Outlier Payment The outlier payment amount is the product of the imputed amount in excess of the outlier threshold absorbed by the HHA and the loss sharing ratio. The outlier payment is added to the sum of the wage and case-mix adjusted 60-day episode amount. The steps to calculate the total episode payment, including an outlier payment, are given below. For this example, assume that a beneficiary lives in Greenville, SC and that the episode in question began and ended in CY 2008. The episode has a case-mix severity = C3F3S5, and is a second episode with 98 visits (40 skilled nursing, 45 home health aide visits, and 13 physical therapy visits). The beneficiary had 105 NRS points, for an NRS severity level = 6. Therefore, from Table 9, the NRS payment amount = $551.00; from Table 5, the case-mix weight = 1.9413; and from Addendum B, the wage index = 0.9860. 1. Calculate case-mix and wage-adjusted 60-day episode payment, including NRS. National standardized 60-day episode payment amount for episodes beginning and ending in CY 2008 = $2,270.32 Calculate the case-mix adjusted episode payment: Multiply the national standardized 60-day episode payment by the applicable case-mix weight: $2,270.32 × 1.9413 = $4,407.37 Divide the case-mix adjusted episode payment into the labor and non-labor portions: Labor portion: 0.77082 × $4,407.37 = $3,397.29 Non-labor portion: 0.22918 × $4,407.37 = $1,010.08 Wage-adjust the labor portion by multiplying it by the wage index factor for Greenville, SC: 0.9860 × $3,397.29 = $3,349.73 Add wage-adjusted labor portion to the non-labor portion to calculate the total case-mix and wage-adjusted 60-day episode payment before NRS added: $3,349.73 + $1,010.08 = $4,359.81 Add NRS amount to get the total case-mix and wage-adjusted 60-day episode payment, including NRS: $551.00 + $4,359.81 = $4,910.81 2. Calculate wage-adjusted outlier threshold. Fixed dollar loss amount = national standardized 60-day episode payment multiplied by 0.89 FDL: $2,270.32 × 0.89 = $2,020.58 Divide fixed dollar loss amount into labor and non-labor portions: Labor portion: 0.77082 × $2,020.58 = $1,557.50 Non-labor portion: 0.22918 × $2,020.58 = $463.08 Wage-adjust the labor portion by multiplying the labor portion of the fixed dollar loss amount by the wage index: $1,557.50 × 0.9860 = $1,535.70 Calculate the wage-adjusted fixed dollar loss amount by adding the wage-adjusted portion of the fixed dollar loss amount to the non-labor portion of the fixed dollar loss amount: $1,535.70 + $463.08 = $1,998.78 Add the case-mix and wage-adjusted 60-day episode amount including NRS and the wage-adjusted fixed dollar loss amount to get the wage-adjusted outlier threshold: $4,910.81 + $1,998.78 = $6,909.59 3. Calculate the wage-adjusted imputed cost of the episode. Multiply the total number of visits by the national average per-visit amounts listed in Table 12: 40 skilled nursing visits × $104.91 = $4,196.40 45 home health aide visits × $47.51 = $2,137.95 13 physical therapy visits × $114.71 = $1,491.23 Calculate the wage-adjusted labor and nonlabor portions for the imputed skilled nursing visit costs: Labor portion: 0.77082 × $4,196.40 = $3,234.67 Non-labor portion: 0.22918 × $4,196.40 = $961.73 Adjust the labor portion of the skilled nursing visits by the wage index: 0.9860 × $3,234.67 = $3,189.38 Add the wage-adjusted labor portion of the skilled nursing visits to the non-labor portion for the total wage-adjusted imputed costs for skilled nursing visits: $3,189.38 + $961.73 = $4,151.11 Calculate the wage-adjusted labor and non-labor portions for the imputed home health aide visits: Labor portion: 0.77082 × $2,137.95 = $1,647.97 Non-labor portion: 0.22918 × $2,137.95 = $489.98 Adjust the labor portion of the home health aide visits by the wage index: 0.9860 × $1,647.97 = $1,624.90 Add the wage-adjusted labor portion of the home health aide visits to the non-labor portion for the total wage-adjusted imputed costs for home health aide visits: $1,624.90 + $489.98 = $2,114.88 Calculate the wage-adjusted labor and non-labor portions for the imputed physical therapy visits: Labor portion: 0.77082 × $1,491.23 = $1,149.47 Non-labor portion: 0.22918 × $1,491.23 = $341.76 Adjust the labor portion of the physical therapy visits by the wage index: 0.9860 × $1,149.47 = $1,133.38 Add the wage-adjusted labor portion of the physical therapy visits to the non-labor portion for the total wage-adjusted imputed costs for physical therapy visits: $1,133.38 + $341.76 = $1,475.14 Total wage adjusted imputed per-visit costs for skilled nursing, home health aide, and physical therapy visits during the 60-day episode: $4,151.11 + $2,114.88 + $1,475.14 = $7,741.13 4. Calculate the amount absorbed by the HHA in excess of the outlier threshold. Subtract the outlier threshold from
(2)from the total wage-adjusted imputed per-visit costs for the episode from (3). $7,741.13 − $6,909.59 = $831.54 5. Calculate the outlier payment and total episode payment. Multiply the imputed amount in excess of the outlier threshold absorbed by the HHA from
(4)by the loss sharing ratio of 0.80: $831.54 × 0.80 = $665.23 = outlier payment Add the outlier payment to the case-mix and wage-adjusted 60-day episode payment, including NRS, calculated in (1): $665.23 + $4,910.81 = $5,576.04 $5,576.04 equals the total payment for the episode, including the outlier payment. 18. On page 49873, in Table 14, in the second column, the CY 2007 per-visit amount “121.22” for speech-language pathology, is corrected to read “121.32”. In addition, in the fifth column, the CY 2008 per-visit amount “122.13” for speech-language pathology is corrected to read “122.23”. 19. On page 49877, in the first column of Table 15, under the impacts by “Type of Facility”, revise the group name “Subtotal: Vol/PNP” to read “Subtotal: Vol/NP”. 20. On page 49880, in Addendum A, in the third column, in line 7, the entry “1.1283” that is displayed as the wage index for CBSA code 07 (rural Connecticut) is corrected to read “1.1711”. 21. On page 49881, in the footnote at the bottom of Addendum A, CY 2007 is corrected to read CY 2008. Additionally, we are correcting the footnote at the bottom of Addendum A to read, “ 1 All counties within the State are classified as urban, with the exception of Massachusetts and Puerto Rico. Massachusetts and Puerto Rico have areas designated as rural; however, no short-term, acute care hospitals are located in the area(s) for CY 2008. The rural Massachusetts wage index is calculated as the average of all contiguous CBSAs. The Puerto Rico wage index is the same as for CY 2007. 22. On page 49890, in Addendum A, in the third column, the entry “0.9353” that is displayed as the wage index for CBSA code 16180 (Carson City, NV) is corrected to read “1.0003”. 23. On page 49901, in Addendum B, in the third column, the entry “1.0937” that is displayed as the wage index value for CBSA code 25540 (Hartford-West Hartford-East Hartford, CT) is corrected to read “1.0930”. 24. On page 49901, in Addendum B, the reference to the footnote for CBSA 25980 and on page 49932 the actual footnote are corrected to read “1”. 25. On page 49918, in Addendum B, in the third column, the entry “1.0959” that is displayed as the wage index for CBSA code 39900 (Reno-Sparks, NV) is corrected to read “1.0715”. 26. On pages 49933, in Addendum C, in the fourth column, in line 7, the entry “1.1283” that is displayed as the wage index for CBSA code 07 (rural Connecticut) is corrected to read “1.1711”. In addition, on page 49933, in Addendum C, in the fifth column, in line 7, the entry of “−3.64” that is displayed as the percent change from CY 07 to CY 08 for CBSA 07 is corrected to read “0.02”. 27. On page 49936, in Addendum C, in the fourth column, in line 14 from the bottom, the entry of “0.9353” that is displayed as the wage index for CBSA code 16180 (Carson City, NV) is corrected to read “1.0003”. In addition, on page 49936, in the fifth column, the entry “−6.70” that is displayed as the percent change from CY 07 to CY 08 for CBSA 16180 is corrected to read “−0.22”. 28. On page 49939, in Addendum C, in the fourth column, in line 3, the entry “1.0937” that is displayed as the wage index for CBSA code 25540 (Hartford-West Hartford-East Hartford, CT) is corrected to read “1.0930”. In addition, on page 49939, in the fifth column, in line 4, the entry “0.39” that is displayed as the percent change from CY 07 to CY 08 for CBSA 25540 is corrected to read “0.33”. 29. On page 49943, in Addendum C, in the fourth column, the entry of “1.0959” that is displayed as the wage index for CBSA code 39900 (Reno-Sparks, NV) is corrected to read “1.0715”. In addition, on page 49943, in the fifth column, the entry “−8.39” that is displayed as the percent change from CY 07 to CY 08 for CBSA 39900 is corrected to read “−10.43”. IV. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the **Federal Register** to provide a period for public comment before the provisions of a notice such as this take effect in accordance with section 553(b) of the Administrative Procedure Act
(APA)(5 U.S.C. 553(b)). However, we can waive both the notice and comment procedure and the 30-day delay in effective date if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice. We find for good cause that it is unnecessary to undertake notice and comment rulemaking because this notice merely provides typographical and technical corrections to the regulations. We are not making substantive changes to our payment methodologies or policies, but rather, are simply implementing correctly the payment methodologies and policies that we previously proposed, received comment on, and subsequently finalized. The public has already had the opportunity to comment on these payment methodologies and policies, and this correction notice is intended solely to ensure that the CY 2008 HH PPS final rule accurately reflects them. Therefore, we believe that undertaking further notice and comment procedures to incorporate these corrections into the CY 2008 HH PPS final rule is unnecessary and contrary to the public interest. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 27, 2007. Ann C. Agnew, Executive Secretary to the Department. [FR Doc. E7-23272 Filed 11-29-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 65 [Docket No. FEMA-B-7750] Changes in Flood Elevation Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Interim rule. SUMMARY: This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations
(BFEs)is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents. DATES: These modified BFEs are currently in effect on the dates listed in the table below and revise the Flood Insurance Rate Maps (FIRMs) in effect prior to this determination for the listed communities. From the date of the second publication of these changes in a newspaper of local circulation, any person has ninety
(90)days in which to request through the community that the Mitigation Assistant Administrator of FEMA reconsider the changes. The modified BFEs may be changed during the 90-day period. ADDRESSES: The modified BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below. FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Engineering Management Section, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-3151. SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided. Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data. The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 *et seq.* , and with 44 CFR part 65. For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals. The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP). These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by the other Federal, State, or regional entities. The changes BFEs are in accordance with 44 CFR 65.4. *National Environmental Policy Act.* This interim rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. *Regulatory Flexibility Act.* As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required. *Regulatory Classification.* This interim rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. *Executive Order 13132, Federalism.* This interim rule involves no policies that have federalism implications under Executive Order 13132, Federalism. *Executive Order 12988, Civil Justice Reform.* This interim rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 65 Flood insurance, Floodplains, Reporting and recordkeeping requirements. Accordingly, 44 CFR part 65 is amended to read as follows: PART 65—[AMENDED] 1. The authority citation for part 65 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 65.4 [Amended] 2. The tables published under the authority of § 65.4 are amended as follows: State and county Location and case No. Date and name of newspaper where notice was published Chief executive officer of community Effective date of modification Community No. Alabama: Madison City of Huntsville (06-04-BY84P) September 21, 2007, September 28, 2007, *Madison County Record* The Honorable Loretta Spencer, Mayor, City of Huntsville, P.O. Box 308, Huntsville, AL 35804 October 1, 2007 010153 Madison Unincorporated areas of Madison County (06-04-BY84P) September 21, 2007, September 28, 2007, *Madison County Record* The Honorable Mike Gillespie, Chairman, Madison County Commission, 6994 Courthouse 700, 100 North Side Square, Huntsville, AL 35801 October 1, 2007 010151 Arizona: Coconino Unincorporated areas of Coconino County (07-09-0172P) September 13, 2007, September 20, 2007, *Arizona Daily Sun* The Honorable Elizabeth Archuleta, Chairperson, Coconino County, Board of Commissioners, 2500 North Fort Valley Road, Building One, Flagstaff, AZ 86001 September 27, 2007 040019 Pima Town of Marana (07-09-1759P) September 6, 2007, September 13, 2007, *The Daily Territorial* The Honorable Ed Honea, Mayor, Town of Marana, Marana Municipal Complex, 11555 West Civic Center Drive, Marana, AZ 85653 December 13, 2007 040118 Pima Unincorporated areas of Pima County (07-09-1759P) September 6, 2007. September 13, 2007, *The Daily Territorial* The Honorable Richard Elias, Chairman, Pima County, Board of Supervisors, 130 West Congress Street, 11th Floor, Tucson, AZ 85701 December 13, 2007 040073 California: San Diego City of Carlsbad (07-09-1622P) October 4, 2007, October 11, 2007, *San Diego Daily Transcript* The Honorable Claude A. Lewis, Mayor, City of Carlsbad, 1200 Carlsbad Village Drive, Carlsbad, CA 92008 September 24, 2007 060285 San Diego City of San Marcos (07-09-1622P) October 4, 2007, October 11, 2007, *San Diego Daily Transcript* The Honorable James Desmond, Mayor, City of San Marcos, One Civic Center Drive, San Marcos, CA 92069 September 24, 2007 060296 San Diego Unincorporated areas of San Diego County (07-09-1622P) October 4, 2007, October 11, 2007, *San Diego Daily Transcript* The Honorable Ron Roberts, Chairman, San Diego County, Board of Supervisors, 1600 Pacific Highway, Room 335, San Diego, CA 92101 September 24, 2007 060284 San Joaquin City of Lathrop (07-09-0844P) September 20, 2007, September 27, 2007, *The Record* The Honorable Apolinar Sangalang, Mayor, City of Lathrop, 16775 Howland Road, Suite One, Lathrop, CA 95330 August 31, 2007 060738 Yuba Unincorporated areas of Yuba County (07-09-1090P) September 20, 2007, September 27, 2007, *Marysville Appeal-Democrat* Mr. Robert Bendorf, County Administrator, Yuba County 915 Eighth Street, Suite 115, Marysville, CA 95901 August 31, 2007 060427 Colorado: Boulder City of Longmont (07-08-0506P) September 6, 2007, September 13, 2007, *The Daily Camera* The Honorable Julia Pirnack, Mayor, City of Longmont, 864 Fourth Avenue, Longmont, CO 80501 December 13, 2007 080027 Boulder Unincorporated areas of Boulder County (07-08-0506P) September 6, 2007, September 13, 2007, *The Daily Camera* The Honorable Ben Pearlman, Chairman, Boulder County, Board of Commissioners, P.O. Box 471, Boulder, CO 80306 December 13, 2007 080023 Georgia: Athens-Clarke Unincorporated areas of Athens-Clarke County (07-04-174P) October 5, 2007, October 12, 2007, *Athens Banner-Herald* The Honorable Heidi Davison, Mayor, Athens-Clarke County, 235 Wells Drive, Athens, GA 30606 September 14, 2007 130040 Barrow Unincorporated areas of Barrow County (07-04-2937P) September 12, 2007, September 19, 2007, *The Barrow County News* The Honorable Douglas H. Garrison, Chairman, Barrow County, Board of Commissioners, 233 East Broad Street, Winder, GA 30680 December 19, 2007 130497 Bryan City of Richmond Hill (07-04-5472P) September 12, 2007, September 19, 2007, *Bryan County News* The Honorable Richard R. Davis, Mayor, City of Richmond Hill, P.O. Box 250, Richmond Hill, GA 31324 December 19, 2007 130018 Bryan Unincorporated areas of Bryan County (07-04-5472P) September 12, 2007, September 19, 2007, *Bryan County news* The Honorable Jimmy Burnsed, Chairman, Bryan County, Board of Commissioners, 116 Lanier Street, Pembroke, GA 31321 December 19, 2007 130016 Cherokee Unincorporated areas of Cherokee County (07-04-3183P) September 14, 2007, September 21, 2007, *Cherokee Tribune* The Honorable Buzz Ahrens, Chairman, Cherokee County, Board of Commissioners, 90 North Street, Suite 310, Canton, GA 30114 August 30, 2007 130424 Gwinnett City of Sugar Hill (07-04-3458P) September 20, 2007, September 27, 2007, *Gwinnett Daily Post* The Honorable Gary Pirkle, Mayor, City of Sugar Hill, 4988 West Broad Street, Sugar Hill, GA 30518 December 27, 2007 130474 Gwinnett Unincorporated areas of Gwinnett County (07-04-3458P) September 20, 2007, September 27, 2007, *Gwinnett Daily Post* The Honorable Charles Bannister, Chairman, Gwinnett County Board of Commissioners, 75 Langley Drive, Lawrenceville, GA 30045 December 27, 2007 130322 Maine: Waldo City of Belfast (07-01-0690P) August 11, 2007, August 16, 2007, *The Republican Journal* Mr. Terrence St. Peter, City Manager, City of Belfast, 131 Church Street, Belfast, ME 04915 July 23, 2007 230129 Maryland: Carroll Unincorporated areas of Carroll County (07-03-0510P) September 13, 2007, September 20, 2007, *Carroll County Times* Ms. Julia W. Gouge, President, Carroll County Board of Commissioners, Carroll County Office Building, 225 North Center Street, Westminster, MD 21157 August 28, 2007 240015 Massachusetts: Plymouth Town of Hanover (07-01-0795P) September 19, 2007, September 26, 2007, *Hanover Mariner* The Honorable R. Alan Rugman, Chairman, Board of Selectmen, 550 Hanover Street, Hanover, MA 02339 December 26, 2007 250266 Minnesota: Polk City of East Grand Forks (07-05-2270P) September 29, 2007, October 3, 2007, *The Exponent* The Honorable Lynn Stauss, Mayor, City of East Grand Forks, City Hall, 600 Demers Avenue, East Grand Forks MN 56721 January 2, 2008 275236 Polk Unincorporated areas of Polk County (07-05-2270P) September 29, 2007, October 3, 2007, *The Exponent* The Honorable Warren Affeldt, Chairman, Polk County Board of Commissioners, 612 North Broadway, Suite 215, Crookston, MN 56716 January 2, 2008 270503 Mississippi: Rankin City of Brandon (07-04-3666P) September 12, 2007, September 19, 2007, *Rankin County News* The Honorable Carlo Martella, Mayor, City of Brandon, P.O. Box 1539, Brandon, MS 39043 August 24, 2007 280143 Rankin City of Pearl (07-04-3666P) September 12, 2007, September 19, 2007, *Rankin County News* The Honorable Jimmy Foster, Mayor, City of Pearl, P.O. Box 5948, Pearl, MS 39288-5948 August 24, 2007 280145 Rankin Unincorporated areas of Rankin County (07-04-3666P) September 12, 2007, September 19, 2007, *Rankin County News* The Honorable Ken Martin, Chairman, Rankin County Board of Supervisors, 211 East Government Street, Suite A, Brandon, MS 39042 August 24, 2007 280142 Missouri: Lincoln Unincorporated areas of Lincoln County (06-07-BA52P) August 22, 2007, August 29, 2007, *The Troy Free Press* The Honorable Sean O'Brien, Presiding Commissioner, Lincoln County, Lincoln County Courthouse, 201 Main Street, Troy, MO 63379 November 28, 2007 290869 St. Louis City of Valley Park (07-07-1587P) September 13, 2007, September 20, 2007, *The St. Louis Daily Record* The Honorable Jeffery Whitteaker, Mayor, City of Valley Park, 320 Benton Street, Valley Park, MO 63088 August 29, 2007 290391 Montana: Lincoln Unincorporated areas of Lincoln County (07-08-0447P) August 2, 2007, August 9, 2007, *Tobacco Valley News* The Honorable Rita Windom, Chairwoman, Lincoln County Board of Commissioners, 512 California Avenue, Libby, MT 59923 July 10, 2007 300157 New Mexico: Bernalillo City of Albuquerque (07-06-1449P) October 4, 2007, October 11, 2007, *The Albuquerque Journal* The Honorable Martin J. Chavez, Mayor, City of Albuquerque, P.O. Box 1293, Albuquerque, NM 87103 September 18, 2007 350002 Sandoval Unincorporated areas of Sandoval County (07-06-1048P) September 20, 2007, September 27, 2007, *The Santa Fe New Mexican* Ms. Debbie Hayes, County Manager, Sandoval County, P.O. Box 40, Bernalillo, NM 87004 August 27, 2007 350055 Nevada: Clark Unincorporated areas of Clark County (06-09-BG37P) September 6, 2007, September 13, 2007, *Las Vegas Review-Journal* The Honorable Rory Reid, Chair, Clark County Board of Commissioners, 500 South Grand Central Parkway, Las Vegas, NV 89106 December 13, 2007 320003 Oklahoma: Carter City of Ardmore (07-06-0167P) September 6, 2007, September 13, 2007, *Daily Ardmoreite* The Honorable John Moore, Mayor, City of Ardmore, P.O. Box 249, Ardmore, OK 73402 December 13, 2007 400031 Rhode Island: Providence City of Cranston (07-01-0910P) August 23, 2007, August 30, 2007, *Cranston Herald* The Honorable Michael Napolitano, Mayor, City of Cranston, Cranston City Hall, 869 Park Avenue, Cranston, RI 02910 July 31, 2007 445396 South Carolina: Aiken City of North Augusta (07-04-2732P) September 13, 2007, September 20, 2007, *Aiken Standard* The Honorable Lark W. Jones, Mayor, City of North Augusta, P.O. Box 6400, North Augusta, SC 29861 August 27, 2007 450007 Texas: Austin City of Sealy (07-06-2014P) September 18, 2007, September 25, 2007, *The Sealy News* The Honorable Russell L. Koym, Mayor, City of Sealy, P.O. Box 517, Sealy, TX 77474 December 26, 2007 480017 Bexar City of San Antonio (06-06-B105P) September 13, 2007, September 20, 2007, *Daily Commercial Recorder* The Honorable Phil Hardberger, Mayor, City of San Antonio, P.O. Box 839966, San Antonio, TX 78283 August 30, 2007 480045 Bexar City of San Antonio (07-06-0793P) September 27, 2007, October 4, 2007, *Daily Commercial Recorder* The Honorable Phil Hardberger, Mayor, City of San Antonio, P.O. Box 839966, San Antonio, TX 78283 January 3, 2008 480045 Brazos City of Bryan (05-06-1677P) September 6, 2007, September 13, 2007, *The Eagle* The Honorable D. Mark Conlee, Mayor, City of Bryan, 300 South Texas Avenue, Bryan, TX 77803 December 13, 2007 480082 Brazos Unincorporated areas of Brazos County (05-06-1677P) September 6, 2007, September 13, 2007, *The Eagle* The Honorable Randy Sims, Brazos County Judge, 300 East 26th Street, Suite 114, Bryan, TX 77803 December 13, 2007 481195 Collin City of Allen (07-06-0941P) August 30, 2007, September 6, 2007, *The Allen American* The Honorable Stephen Terrell, Mayor, City of Allen, 305 Century Parkway, Allen, TX 75013 August 16, 2007 480131 Collin City of Anna (07-06-1349P) September 13, 2007, September 20, 2007, *McKinney Courier-Gazette* The Honorable Kenneth Pelham, Mayor, City of Anna, P.O. Box 776, Anna, TX 75409 December 20, 2007 480132 Dallas City of Irving (06-06-BA90P) September 20, 2007, September 27, 2007, *Dallas Morning News* The Honorable Herbert A. Gears, Mayor, City of Irving, 825 West Irving Boulevard, Irving, TX 75060 December 27, 2007 480180 Harris Unincorporated areas of Harris County (07-06-1673P) September 20, 2007, September 27, 2007, *Houston Chronicle* The Honorable Ed Emmett, Harris County Judge, 1001 Preston, Suite 911, Houston, TX 77002 December 27, 2007 480287 Montgomery Unincorporated areas of Montgomery County (07-06-1001P) September 12, 2007, September 19, 2007, *The Montgomery County News* The Honorable Alan B. Sadler, County Judge, Montgomery County, 301 North Thompson, Suite 210, Conroe, TX 77301 October 1, 2007 480483 Tarrant City of Fort Worth (07-06-0876P) September 13, 2007, September 20, 2007, *Fort Worth Star-Telegram* The Honorable Mike J. Moncrief, Mayor, City of Fort Worth, 1000 Throckmorton Street, Fort Worth, TX 76102 December 20, 2007 480596 Tarrant City of Fort Worth (07-06-0930P) September 20, 2007, Septebmer 27, 2007, *Fort Worth Star-Telegram* The Honorable Mike J. Moncrief, Mayor, City of Fort Worth, 1000 Throckmorton Street, Fort Worth, TX 76102 December 27, 2007 480596 Tarrant City of Fort Worth (07-06-1902P) September 20, 2007, September 27, 2007, *Fort Worth Star-Telegram* The Honorable Mike J. Moncrief, Mayor, City of Fort Worth, 1000 Throckmorton Street, Fort Worth, TX 76102 August 31, 2007 480596 Williamson City of Round Rock (07-06-2615P) September 18, 2007, September 25, 2007, *Round Rock Leader* The Honorable Nyle Maxwell, Mayor, City of Round Rock, 221 East Main Street, Round Rock, TX 78664 December 26, 2007 481048 Williamson Unincorporated areas of Williamson County (07-06-2615P) September 18, 2007, September 25, 2007, *Round Rock Leader* The Honorable Dan A. Gattis, Williamson County Judge, 301 Southeast Inner Loop, Suite 109, Georgetown, TX 78626 December 26, 2007 481079 Virginia: Chesterfield Unincorporated areas of Chesterfield County (07-03-1156P) September 20, 2007 September 27, 2007 *Richmond Times-Dispatch* The Honorable Kelly E. Miller, Chairman, Chesterfield County, Board of Supervisors, P.O. Box 40, Chesterfield, VA 23832-0040 December 27, 2007 510035 Fauquier Unincorporated areas of Fauquier County (07-03-1036P) September 12, 2007 September 19, 2007 *Fauquier Times Democrat* Mr. Harry Atherton, Chairman, Fauquier County, Board of Supervisors, Ten Hotel Street, Suite 208, Warrenton, VA 20186 February 7, 2008 510055 Wisconsin: Waukesha Village of Dousman (06-05-B016P) September 27, 2007 October 4, 2007 *The Freeman* The Honorable Jack Nissen, Village President, Village of Dousman, 118 South Main Street, Dousman, WI 53118 January 3, 2008 550480 Waukesha Unincorporated areas of Waukesha County (06-05-B016P) September 27, 2007 October 4, 2007 *The Freeman* The Honorable Daniel Vrakas, County Executive, Waukesha County, 1320 Pewaukee Road, Room 320, Waukesha, WI 53188 January 3, 2008 550476 Sweetwater City of Rock Springs (07-08-0796P) September 22, 2007 September 27, 2007 *Rock Springs Daily Rocket-Miner* The Honorable Timothy A. Kaumo, Mayor, City of Rock Springs, 212 D Street, Rock Springs, WY 82901 October 1, 2007 560051 Wyoming: Sweetwater Unincorporated areas of Sweetwater County (07-08-0796P) September 22, 2007 September 27, 2007 *Rock Springs Daily Rocket-Miner* The Honorable Wally Johnson, Chairman, Sweetwater County, Board of Commissioners, 80 West Flamingo Gorge Way, Green River, WY 82935 October 1, 2007 560087 (Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”) Dated: November 19, 2007. David I. Maurstad, Federal Insurance Administrator of the National Flood Insurance Program, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E7-23214 Filed 11-29-07; 8:45 am] BILLING CODE 9110-12-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-4470; MB Docket No. 07-130; RM-11372] Radio Broadcasting Services; Silverton, CO AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: At the request of Laramie Mountain Broadcasting, LLC, Channel 281A is allotted at Silverton, Colorado, as the community's second local aural transmission service. Channel 281A is allotted at Silverton, Colorado, without a site restriction at coordinates 37-48-43 NL and 107-39-50 WL. DATES: Effective December 17, 2007. ADDRESSES: Secretary, Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Victoria McCauley, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's Report and Order, MB Docket No. 07-130, adopted October 31, 2007, and released November 2, 2007. The *Notice of Proposed Rule Making* proposed the allotment of Channel 281A at Silverton, Colorado. *See* 72 FR 42016, published August 1, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street, SW., Washington, DC 20554. This document may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR Part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for Part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Colorado is amended by adding Silverton, Channel 281A. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-23299 Filed 11-29-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-4503; MB Docket No. 07-174; RM-11387] Radio Broadcasting Services; Walden, CO AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Audio Division, at the request of Laramie Mountain Broadcasting, LLC, allots Channel 226C3 at Walden, Colorado, as the community's second local FM service. Channel 226C3 can be allotted to Walden, Colorado, in compliance with the Commission's minimum distance separation requirements with a site restriction of 20.6 km (12.8 miles) west of Walden, at the following reference coordinates: 40-42-01 North Latitude and 106-31-21 West Longitude. DATES: Effective December 17, 2007. ADDRESSES: Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Deborah Dupont, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order* , MB Docket No. 07-174, adopted October 31, 2007, and released November 2, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554,
(800)378-3160, or via the company's Web site, *http://www.bcpiweb.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR Part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for Part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Colorado, is amended by adding Walden, Channel 226C3. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-23301 Filed 11-29-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-4469; MB Docket No. 07-176; RM-11389] Radio Broadcasting Services; Humboldt, NE AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Audio Division, at the request of Cumulus Licensing LLC, allots Channel 272C3 at Humboldt, Nebraska, as the community's first local FM service. Channel 272C3 can be allotted to Humboldt, Nebraska, in compliance with the Commission's minimum distance separation requirements without site restriction at city reference coordinates: 40-09-51 North Latitude and 95-56-40 West Longitude. DATES: Effective December 17, 2007. ADDRESSES: Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Deborah Dupont, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order* , MB Docket No. 07-176, adopted October 31, 2007, and released November 2, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554,
(800)378-3160, or via the company's Web site, *http://www.bcpiweb.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR Part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for Part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Nebraska, is amended by adding Humboldt, Channel 272C3. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-23302 Filed 11-29-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 [Docket No. 071002553-7554-01] RIN 0648-AW14 Pacific Halibut Fisheries; Correction AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Correcting amendment. SUMMARY: NMFS issues this correcting amendment to the Code of Federal Regulations
(CFR)to correct typographical errors and update cross references in three sections of the Pacific halibut fishery regulations; definitions, catch sharing plan and domestic management measures in waters in and off Alaska, and prohibitions. This correcting amendment improves the accuracy of Pacific halibut fisheries regulations, makes minor, non-substantive changes, and does not change operating practices in halibut fisheries or the rights and obligations of fishermen managed under the halibut regulations. DATES: November 30, 2007. FOR FURTHER INFORMATION CONTACT: Peggy Murphy, NMFS, 907-586-7228 or email at *peggy.murphy@noaa.gov* . SUPPLEMENTARY INFORMATION: Background The International Pacific Halibut Commission (Commission) and NMFS manage fishing for Pacific halibut ( *Hippoglossus stenolepis* ) through regulations established under the authority of the Northern Pacific Halibut Act of 1982 (Halibut Act). The Commission promulgates regulations governing the Pacific halibut fishery between the United States and Canada for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Convention), signed in Ottawa, Ontario, on March 2, 1953, and by Protocol Amending the Convention signed at Washington, D.C., on March 29, 1979. The Commission's regulations are subject to approval by the Secretary of State with concurrence of the Secretary of Commerce (Secretary). Approved regulations developed by the Commission are published as annual management measures pursuant to 50 CFR 300.62. The North Pacific Fishery Management Council (Council) may also recommend regulations that comply with approved Commission regulations and are implemented by the Secretary through NMFS. Federal regulations for Pacific halibut fisheries in Alaska are codified at 50 CFR part 300. On occasion, new and revised regulations are published in the CFR with minor technical mistakes, such as spelling errors or no space between two words. These unintended errors are fixed through a correcting amendment. The Council implemented guideline harvest levels
(GHL)in Commission regulatory areas 2C and 3A on August 8, 2003, to more comprehensively manage the charter vessel fishery for Pacific halibut stocks in waters in and off Alaska (68 FR 47256). The final rule added a text table at § 300.65(c)(1) with typographical errors in the column headings. Also, the estimated charter vessel harvest of halibut in Commission regulatory area 2C in 2006 exceeded the GHL specified for that area. This triggered issuance of a regulation to restrict the size of fish harvested in the 2007 fishing season and reduce the charter vessel harvest of halibut in Area 2C. A final rule implementing this regulation was effective June 1, 2007 (June 4, 72 FR 30714). If the final rule were not effective by this date, the conservation and management objective of the action would have been jeopardized because the estimated reduction in weight of halibut caught in the Area 2C charter vessel fishery was based on an assumption that the final rule would be effective for the full charter fishing season of June, July and August. Effort was escalated to complete the proposed and final rule making process and good cause was found by the Assistant Administrator for Fisheries, NOAA to waive the 30-day delay in the effective date of the action under 5 U.S.C. 553(d)(3). The final rule did not change the existing daily bag limit of two halibut, but required that one of the two fish retained by persons sport fishing on a charter vessel operating in Area 2C be no more than 32 inches (81.3 cm) in length. The rule added a new paragraph, (d), to § 300.65 incrementing the alphabetic reference to existing paragraphs
(d)through
(k)to
(e)through (l), respectively. However, in our haste, NMFS did not update the cross references to paragraphs that had changed after the new paragraph
(d)was added. Only the first level paragraph designations were changed, subparagraphs designations erroneously remained unchanged. Need for Correction This correcting amendment is necessary to correct the typographical errors in the column headings to the GHL table at § 300.65(c)(1) and update cross references to paragraphs in the CFR at § 300.61, 300.65, and 300.66. Minor errors in spacing between words are also corrected at § 300.65(c)(2) and § 300.65(k) and an indefinite article is corrected at § 300.65(k)(2)(i)(D). These changes are needed to provide consistent reference, and make the regulations more understandable and effective. The GHL table is structured conditionally, so if specified criteria are met, then a particular action or outcome is defined to occur. In this case, when the annual total constant exploitation yield for halibut in Area 2C (or 3A) is more than one of the poundages (tonnages) listed, then the annual GHL is set to the corresponding poundage (tonnage) specified for that area (2C or 3A). Currently, the column headings read “than” instead of “then,” so the intended functional comparison using “If/Then” statements need to be corrected to make sense. Current paragraph lettering at §§ 300.61, 300.65, and 300.66 is correct but cross references to paragraphs are incorrect and need to updated. The text of each change is set forth in sequential order in the add/remove table of this correcting amendment. NMFS chose to display these changes in a table because simple changes are more efficiently shown in an add/remove table than by reprinting the full regulatory text. Classification Pursuant to 5 U.S.C. 553(b)(B) of the Administrative Procedure Act, the Assistant Administrator for Fisheries finds good cause to waive the requirement to provide prior notice and opportunity for public comment on this correcting amendment to the Pacific halibut fisheries regulations. Notice and comment are unnecessary and contrary to the public interest because this action makes only minor, non-substantive changes to correct typographical errors in a table's column headings, and updates paragraph and section cross references. Minimizing the duration of time the errors are published will reduce reader confusion. Timely correction of the rule will improve public understanding of the regulations. The rule does not make any substantive change in the rights and obligations of halibut fishermen. No change in operating practices in the fisheries is required. Because this action makes only the minor, non-substantive change to § 300.61, 300.65, and 300.66 described above, this rule is not subject to the 30-day delay in effective date requirement of 5 U.S.C. 553(d). List of Subjects in 50 CFR Part 300 Alaska, Fisheries, Recordkeeping and reporting requirements. Dated: November 26, 2007. Samuel D. Rauch III, Deputy Assistent Administrator For Regulatory Programs, National Marine Fisheries Service. Accordingly, 50 CFR part 300 is corrected by making the following correcting amendment: PART 300—INTERNATIONAL FISHERIES REGULATIONS Subpart E Pacific Halibut Fisheries 1. The authority citation for 50 CFR part 300, subpart E, continues to read as follows: Authority: 16 U.S.C. 773-773k. **§§ 300.61, 300.65, and 300.66 [Amended]** 2. At each of the locations shown in the “Location” column, remove the phrase indicated in the “Remove” column and replace it with the phrase indicated in the “Add” column for the number of times indicated in the “Frequency” column. Location Remove Add Frequency § 300.61 definition of “Alaska Native tribe” § 300.65(f)(2) § 300.65(g)(2) 1 § 300.61 definition of “Rural” § 300.65(f)(1) § 300.65(g)(1) 1 § 300.61 definition of Rural resident § 300.65(f)(1) § 300.65(g)(1) 2 § 300.65(c)(1) The table title heading in column 2. Than the GHL for Area 2C will be: Then the GHL for Area 2C will be: 1 § 300.65(c)(1) The table title heading in column 4. Than the GHL for Area 3A will be: Then the GHL for Area 3A will be: 1 § 300.65(c)(2) NMFS will publish a notice in the *Federal Register* on NMFS will publish a notice in the *Federal Register* on 1 § 300.65(e)(1)(i) paragraph (d)(2) paragraph (e)(2) 1 § 300.65(e)(1)(ii) paragraphs (d)(3) and (d)(4) paragraphs (e)(3) and (e)(4) 1 § 300.65(e)(2) paragraph (d)(1)(i) paragraph (e)(1)(i) 1 § 300.65(e)(3)(i) paragraph (d)(1)(ii) paragraph (e)(1)(ii) 1 § 300.65(e)(3)(ii) paragraph (d)(1)(ii) paragraph (e)(1)(ii) 1 § 300.65(e)(4) paragraph (d)(1)(ii) paragraph (e)(1)(ii) 1 § 300.65(e)(4)(i) paragraph (d)(1)(ii) paragraph (e)(1)(ii) 1 § 300.65(e)(4)(ii) paragraphs (d)(4) and (d)(4)(i) paragraphs (e)(4) and (e)(4)(i) 1 § 300.65(e)(4)(ii) paragraph (d)(1)(ii) paragraph (e)(1)(ii) 2 § 300.65(f) paragraph
(e)paragraph
(f)1 § 300.65(g) paragraphs (f)(1) or (f)(2) paragraphs (g)(1) or (g)(2) 1 § 300.65(h) paragraph
(f)paragraph
(g)1 § 300.65(h) paragraph
(h)paragraph
(i)1 § 300.65(h)(1)(i) paragraph
(h)paragraph
(i)1 § 300.65(h)(1)(i)(C) paragraph
(j)paragraph
(k)1 § 300.65(h)(2) paragraph
(g)paragraph
(h)1 § 300.65(h)(2)(ii) paragraph
(i)paragraph
(j)1 § 300.65(h)(2)(iii) paragraph
(j)paragraph
(k)1 § 300.65(h)(4) paragraph (g)(3) paragraph (h)(3) 1 § 300.65(h)(4) paragraph
(h)paragraph
(i)1 § 300.65(h)(4)(i) paragraph (f)(2) paragraph (g)(2) 1 §300.65(h)(4)(ii) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(i)(1) paragraph (h)(2) paragraph (i)(2) 1 § 300.65(i)(1) paragraph
(f)paragraph
(g)2 § 300.65(i)(2)(i) 50 CFR 300.65(f)(1) 50 CFR 300.65(g)(1) 1 § 300.65(i)(2)(ii) 50 CFR 300.65(f)(2) 50 CFR 300.65(g)(2) 1 § 300.65(i)(3) paragraph
(f)paragraph
(g)1 § 300.65(i)(3) paragraph (h)(2) paragraph (i)(2) 1 § 300.65(i)(3)(i) paragraph (f)(1) paragraph (g)(1) 1 § 300.65(i)(3)(ii) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(j) paragraphs (f)(1) and (f)(2) paragraphs (g)(1) and (g)(2) 1 § 300.65(j)(1)(i) paragraph (i)(2) paragraph (j)(2) 1 § 300.65(j)(1)(i) paragraph
(f)paragraph
(g)1 § 300.65(j)(1)(ii)(A) paragraph (f)(1) paragraph (g)(1) 1 § 300.65(j)(1)(ii)(B) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(j)(1)(iii) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(j)(2)(ii) paragraph (f)(1) paragraph (g)(1) 1 § 300.65(j)(2)(ii) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(j)(3)(i)(A) paragraph
(d)paragraph
(e)1 § 300.65(j)(3)(i)(B) paragraph
(g)paragraph
(h)1 § 300.65(j)(3)(ii) paragraph
(h)paragraph
(i)1 § 300.65(j)(3)(iv) paragraph
(g)paragraph
(h)1 § 300.65(j)(4) paragraph
(f)paragraph
(g)2 § 300.65(j)(4) paragraph (i)(2) paragraph (j)(2) 1 § 300.65(j)(6) paragraph (i)(2) paragraph (j)(2) 1 § 300.65(k) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(k) §679.4(a)of §679.4(a) of 1 § 300.65(k)(1)(i) paragraph (j)(2) paragraph (k)(2) 1 § 300.65(k)(1)(i) paragraph (f)(2) paragraph (g)(2) 1 § 300.65(k)(2)(i)(D) for a Educational for an Educational 1 § 300.65(k)(3)(i) paragraph
(g)paragraph
(h)1 § 300.65(k)(3)(ii) paragraph
(g)paragraph
(h)1 § 300.65(k)(3)(v) paragraph
(h)paragraph
(i)1 § 300.65(k)(3)(vi) paragraph
(g)paragraph
(h)1 § 300.65(k)(4) paragraph (f)(2) paragraph (g)(2) 2 § 300.65(k)(6) paragraph (j)(2) paragraph (k)(2) 1 § 300.66(c) 300.65
(d)300.65
(e)1 § 300.66(d) 300.65
(e)300.65
(f)1 § 300.66(e) § 300.65
(f)§ 300.65(g) 1 § 300.66(e) § 300.65
(h)§ 300.65(i) 1 § 300.66(e) § 300.65
(j)§ 300.65(k) 1 § 300.66(f) 50 CFR 300.65(g)(1) 50 CFR 300.65(h)(1) 1 § 300.66(f) 50 CFR 300.65(g)(2) 50 CFR 300.65(h)(2) 1 § 300.66(g) 50 CFR 300.65(g)(3) 50 CFR 300.65(h)(3) 1 § 300.66(h) § 300.61(b) § 300.61 1 § 300.66(h) § 300.65(f) § 300.65(g) 1 § 300.66(j) 50 CFR 300.65(f) 50 CFR 300.65(g) 1 § 300.66(j) 50 CFR 300.65(h) 50 CFR 300.65(i) 1 [FR Doc. E7-23268 Filed 11-29-07; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 040112010-4114-02] RIN 0648-XE06 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Modification of the Yellowtail Flounder Landing Limit for the U.S./Canada Management Area AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; trip limit change. SUMMARY: NMFS announces that the Administrator, Northeast
(NE)Region, NMFS (Regional Administrator), is increasing the Georges Bank
(GB)yellowtail flounder trip limit to 7,500 lb (3,402 kg) for NE multispecies days-at-sea
(DAS)vessels fishing in the U.S./Canada Management Area. This action is authorized by the regulations implementing Amendment 13 to the NE Multispecies Fishery Management Plan and is intended to prevent under-harvesting of the Total Allowable Catch
(TAC)for GB yellowtail flounder while ensuring that the TAC will not be exceeded during the 2007 fishing year. This action is being taken to provide additional opportunities for vessels to fully harvest the GB yellowtail flounder TAC under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). DATES: Effective November 27, 2007, through April 30, 2008. FOR FURTHER INFORMATION CONTACT: Mark Grant, Fishery Management Specialist,
(978)281-9145, fax
(978)281-9135. SUPPLEMENTARY INFORMATION: Regulations governing the GB yellowtail flounder landing limit within the U.S./Canada Management Area are found at § 648.85(a)(3)(iv)(C) and (D). The regulations authorize vessels issued a valid Federal limited access NE multispecies permit and fishing under a NE multispecies DAS to fish in the U.S./Canada Management Area, as defined at § 648.85(a)(1), under specific conditions. The TAC for GB yellowtail flounder for the 2007 fishing year (May 1, 2007 - April 30, 2008) is 900 mt. The regulations at § 648.85(a)(3)(iv)(D) authorize the Regional Administrator to increase or decrease the trip limits in the U.S./Canada Management Area to prevent over-harvesting or under-harvesting the TAC allocation. On April 24, 2007 (72 FR 20287), based upon the reduced 2007 TAC for GB yellowtail flounder (a 43 reduction from 2006) and projections of harvest rates in the fishery, the trip limit for GB yellowtail flounder was set at 3,000 lb (1,361 kg) for the 2007 fishing year, to prevent the over-harvest of the 2007 GB yellowtail flounder TAC, to prevent a premature closure of the Eastern U.S./Canada Management Area and, therefore, reduced opportunities to fish for Eastern GB cod and haddock in the Eastern U.S./Canada Area. According to the most recent Vessel Monitoring System
(VMS)reports and other available information, only 45 percent of the TAC had been harvested as of November 21, 2007. Of this total, discards account for over 36 percent of the GB yellowtail harvest to date. Based on this information, the Regional Administrator has determined that the current rate of harvest will result in the under-harvest of the GB yellowtail flounder TAC during the 2007 fishing year. Increasing the GB yellowtail flounder trip limit from 3,000 lb (1,361 kg) to 7,500 lb (3,402 kg) is expected to increase landings of GB yellowtail flounder, reduce discards, and result in the achievement of the TAC during the fishing year without exceeding it. Based on this information, the Regional Administrator is increasing the current 3,000-lb (1,361-kg) trip limit in the U.S./Canada Area to 7,500 lb (3,402 kg), effective November 27, 2007, through April 30, 2008. GB yellowtail flounder landings will continue to be closely monitored. Should 100 percent of the TAC allocation for GB yellowtail flounder be projected to be harvested, the Eastern U.S./Canada Management Area will close to all groundfish DAS vessels, and all vessels will be prohibited from harvesting, possessing, or landing yellowtail flounder from the U.S./Canada Management Area for the remainder of the fishing year. Classification This action is authorized by 50 CFR part 648 and is exempt from review under Executive Order 12866. Pursuant to 5 U.S.C. 553(b)(3)(B) and (d)(3), there is good cause to waive prior notice and opportunity for public comment, as well as the delayed effectiveness for this action, because prior notice and comment and a delayed effectiveness would be impracticable and contrary to the public interest. This action would relieve a restriction by increasing the trip limit for GB yellowtail flounder for all NE multispecies DAS vessels through April 30, 2008, to facilitate the harvest of the TAC for GB yellowtail flounder while ensuring that the TAC will not be exceeded during the 2007 fishing year. This will result in decreased regulatory discards of GB yellowtail flounder, increased revenue for the NE multispecies fishery, and an increased chance of achieving optimum yield in the groundfish fishery. This action is authorized by the regulations at § 648.85(a)(3)(iv)(D) to facilitate achieving the U.S./Canada Management Area TACs. It is important to take this action immediately because the current restrictive GB yellowtail flounder trip limit (3,000 lb, 1,361 kg) has resulted in a high discard rate of GB yellowtail flounder (36 percent) and has prevented the NE multispecies fishery from harvesting the TAC at a rate that will result in complete harvest by the end of the 2007 fishing year. Delay in the implementation of this action could result in further wasteful discards of GB yellowtail flounder and decrease the opportunity available for vessels to fully harvest the 2007 GB yellowtail flounder TAC. The time necessary to provide for prior notice, opportunity for public comment, and delayed effectiveness for this action would prevent NE multispecies DAS vessels from efficiently targeting GB yellowtail flounder in the U.S./Canada Management Area. The Regional Administrator's authority to increase trip limits for GB yellowtail flounder in the U.S./Canada Management Area to help ensure that the shared U.S./Canada stocks of fish are harvested, but not exceeded, was considered and open to public comment during the development of Amendment 13 and Framework Adjustment 42. Further, the potential of increasing the GB yellowtail flounder trip limit was announced to the public when the 3,000-lb (1,361-kg) trip limit was announced prior to the start of the 2007 fishing year. Therefore, any negative effect the waiving of public comment and delayed effectiveness may have on the public is mitigated by these factors. Authority: 16 U.S.C. 1801 *et seq.* Dated: November 27, 2007. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 07-5887 Filed 11-27-07; 2:08 pm]
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88 references not yet in our index
  • 7 CFR 319
  • 7 CFR 2.22
  • 9 CFR 78
  • Pub. L. 106-387
  • Pub. L. 107-56
  • Pub. L. 108-75
  • 15 CFR 730
  • 15 CFR 734
  • 15 CFR 742
  • 15 CFR 743
  • 15 CFR 744
  • 15 CFR 745
  • 15 CFR 746
  • 15 CFR 747
  • 15 CFR 754
  • 15 CFR 756
  • 15 CFR 760
  • 15 CFR 762
  • 15 CFR 764
  • 15 CFR 766
  • 15 CFR 768
  • 10 USC 7430(e)
  • 15 CFR 732
  • 15 CFR 736
  • 15 CFR 738
  • 15 CFR 740
  • Pub. L. 108-11
  • 117 Stat. 559
  • Pub. L. 106-508
  • 15 CFR 748
  • 15 CFR 750
  • 15 CFR 752
  • 15 CFR 758
  • 15 CFR 770
  • 15 CFR 772
  • 15 CFR 774
  • 21 CFR 130.102
  • 5 USC 601-612
  • 21 CFR 310
  • 21 CFR 369
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U.S.C.§ 7201
U.S.C.§ 7210
U.S.C.§ 2151
Fed. Reg.Notices
U.S.C.§ 3501
F. App'x587 F.2d 1173
F. App'x422 F.2d 944
F. App'x366 F.2d 177
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